Promethazine Hydrochloride

Class: First Generation Antihistamines
VA Class: CN309
CAS Number: 58-33-3
Brands: Phenadoz, Phenergan, Promethegan, Prometh VC

• Children <2 Years of Age


• 
  

  Promethazine is contraindicated in pediatric patients <2 years of age, because of risk of developing potentially fatal respiratory depression.^{117 132 133 134 135 136}

  
  

• Respiratory Depression in Children <2 Years of Age


• 
  

  Postmarketing reports of respiratory depression, including fatalities, in pediatric patients <2 years of age receiving a wide range of weight-adjusted doses.^{117 133 134 135 136}

  
  

• Children ≥2 Years of Age


• 
  

  Administer with caution.^{117 132 133 134 135 136}

  
  


• 
  

  Use the lowest effective dose.^{117 132 133}

  
  


• 
  

  Avoid concomitant use with other respiratory depressant drugs.^{117 132 133}

  
  

• Warnings Regarding Parenteral Administration


• 
  

  Because of risk of severe tissue injury, including gangrene requiring amputation, following IV administration of promethazine, FDA states that the preferred route of administration is deep IM injection.^{139 140}

  
  

  Perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration of promethazine may result in irritation and tissue damage.^{139 140} Healthcare professionals should be alert for signs and symptoms of potential tissue injury, including burning or pain at the site of injection, phlebitis, swelling, and blistering.¹³⁹ (See IV Administration under Dosage and Administration and see Precautions Associated with Parenteral Administration under Cautions.)

  
  


• 
  

  FDA has notified healthcare professionals that a Boxed Warning describing these risks is being added to the prescribing information for promethazine hydrochloride.^{139 140}

  
  

Introduction

An ethylamino derivative of phenothiazine with potent first generation antihistaminic properties.^{134 136 a b}

Uses for Promethazine Hydrochloride

Nasal Allergies and the Common Cold

Management of seasonal allergic rhinitis (e.g., hay fever) and perennial (nonseasonal) allergic rhinitis.^{100 133 136}

Management of seasonal nonallergic (vasomotor) rhinitis.¹³³

Symptomatic relief of rhinorrhea and sneezing associated with the common cold.^c

Other Allergic Conditions

Adjunct to epinephrine and other standard measures in the treatment of anaphylactic reactions after the acute manifestations have been controlled.^{100 117 133 136}

Used IM for management of other uncomplicated allergic reactions of the immediate type when oral therapy is impossible or contraindicated.¹¹⁷

Prevention and treatment of mild, uncomplicated skin manifestations of urticaria and angioedema.^{100 133 136}

Management of allergic conjunctivitis caused by foods or inhaled allergens.^{133 136}

Treatment of mild transfusion reactions not caused by ABO incompatibility or pyrogens.^{100 117 133 136 c}

Treatment of dermatographism.^{100 133 136}

Sedation

Treatment to produce sedation in surgery and obstetrics (during labor); reduces preoperative tension and anxiety, facilitates sleep.^{100 117 133 136}

Routine sedation.^{100 117 133 136 b}

Pain

Adjunct to analgesics (e.g., opiates) for management of pain (e.g., postoperative).^{100 117 133 136 b}

Used IV as adjunct to analgesics (e.g., opiates) and anesthesia during surgery (e.g., bronchoscopy, ophthalmic surgery) and in poor-risk patients.¹¹⁷

Motion Sickness

Prevention and treatment of nausea, vomiting, and/or vertigo associated with motion sickness.^{100 117 133 136 a}

Nausea and Vomiting

Prevention and management of nausea and vomiting of various etiologies (e.g., anesthesia, surgery, postoperative).^{100 117 133 136 b}

Hemolytic Disease of the Newborn†

May ameliorate hemolytic disease of the newborn† (erythroblastosis fetalis) when administered during pregnancy in Rh-sensitized women.^{102 103 104 105}

Promethazine Hydrochloride Dosage and Administration

Administration

Administer orally, rectally, or by deep IM injection.^{117 136 a b} Also administered by IV injection.^{117 136 a b} However, FDA states that deep IM injection is the preferred method for administration of promethazine hydrochloride injection because of risks associated with IV administration (see Warnings Regarding Parenteral Administration under Boxed Warning).^{139 140}

FDA states that sub-Q or intra-arterial injection is contraindicated.^{139 140} (See Precautions Associated with Parenteral Administration under Cautions.)

IV Administration

If IV administration is required, administer through tubing of an IV infusion set that is known to be correctly functioning.¹³⁹

If patient complains of pain at the injection site during presumed IV injection, immediately discontinue injection and evaluate the possibility of intra-arterial placement of the needle or perivascular extravasation.^{117 139}

Promethazine hydrochloride injection is commercially available in 2 strengths: 25 mg/mL and 50 mg/mL.^{117 139} FDA states that the preparation containing 50 mg/mL is for IM injection only; the preparation containing 25 mg/mL may be administered by IM or IV injection.¹³⁹

Maximum concentration of the injection is 25 mg/mL.¹¹⁷

Rate of Administration

Maximum rate of IV administration is 25 mg/minute.^{117 139} (See Cardiovascular Effects under Cautions.)

Dosage

Dosages of promethazine hydrochloride by the various routes of administration are identical.^{a b}

Parenteral and rectal routes are used when oral administration is not feasible; institute oral therapy as soon as possible.^a

When used for management of common cold, administer only for short-term due to toxic potential of long-term therapy.^{128 129}

When used for allergic conditions, administer at bedtime because of pronounced sedative effects; adjust dosage to the smallest amount adequate to relieve symptoms.^{100 133 a}

Pediatric Patients

Common Cold

Oral

Children 2 to <6 years of age (as directed by a clinician): 1.56 mg every 4–6 hours.¹²⁸ (See Pediatric Use under Cautions.)

Children 6 to <12 years of age: 3.125 mg every 4–6 hours.¹²⁸

Children ≥12 years of age: 6.25 mg every 4–6 hours.^{128 129}

Allergic Conditions

Oral

Children ≥2 years of age: up to 25 mg at bedtime or up to 12.5 mg 3 times daily (should be adjusted to age and weight).^{100 a} Alternatively, 0.5 mg/kg at bedtime or 0.125 mg/kg as needed.^a

Rectal , IM, or IV

May be administered rectally, by deep IM, or IV^{117 133} in dosages identical to oral dosages.

Sedation

Preoperative or Postoperative Sedation

Oral, Rectal, IM, or IV

Children ≥2 years of age: 12.5–25 mg or 0.5–1.1 mg/kg.^{117 133 a}

Routine Sedation

Oral or Rectal

Children ≥2 years of age: 12.5–25 mg or 0.5–1.1 mg/kg.^{133 a}

Pain

Adjunct to Analgesics

Oral, Rectal, IM, or IV

Children ≥2 years of age: 12.5–25 mg or 0.5–1.1 mg/kg; reduce analgesic dosage accordingly.^{117 133 a}

Motion Sickness

Oral or Rectal

Children ≥2 years of age: 12.5–25 mg or 0.5 mg/kg administered at least 30–60 minutes prior to departure.¹³³ Administer a second dose 8–12 hours later if necessary; additional doses may be given on arising in the morning and before the evening meal for the duration of the journey.^{133 a}

Nausea and Vomiting

Oral or Rectal

Children ≥2 years of age: Usually, 1.1 mg/kg; should be adjusted to age, weight, and severity of condition.^{100 133} Alternatively, 0.25–0.5 mg/kg or 7.5–15 mg/m² 4–6 times daily.^b

IM or IV

Children ≥2 years of age: 0.25–0.5 mg/kg or 7.5–15 mg/m² 4–6 times daily.^b

Adults

Common Cold

Oral

6.25 mg every 4–6 hours.^{128 129}

Allergic Conditions

Oral

25 mg before retiring.^{100 133} Alternatively, 12.5 mg administered before meals and on retiring.^{133 a}

Rectal, IM, or IV

25 mg; dose may be repeated within 2 hours if necessary.^{117 133 a}

Transfusion Reactions

25 mg administered prior to or during a blood transfusion.^{117 133 a}

Sedation

Preoperative or Postoperative Sedation

Oral or Rectal

For preoperative sedation, a 50-mg dose may be administered the night before surgery and 50 mg usually is given before surgery.¹³³

For postoperative sedation, 25–50 mg is used.¹³³

IM or IV

25–50 mg.¹¹⁷

Routine Sedation

Oral, Rectal, IM, or IV

25–50 mg.^{100 117 133}

Sedation in Obstetric Patients

IM or IV

50 mg administered during the early stage of labor.¹¹⁷ When labor is established, 25–75 mg is given with a reduced dose of an opiate agonist.¹¹⁷ 25–50 mg doses may be repeated once or twice at 4-hour intervals if necessary.^{117 a}

Pain

Adjunct to Analgesics

Oral, Rectal, IM or IV

25–50 mg; reduce analgesic dosage accordingly.^{117 133 a}

Motion Sickness

Oral

25 mg administered at least 30–60 minutes prior to departure.^{100 133 a} Administer 25 mg 8–12 hours later if necessary; additional doses may be given on arising in the morning and before the evening meal for the duration of the journey.^{100 133 a}

Nausea and Vomiting

Oral, Rectal, IM, or IV

12.5–25 mg;^{100 117 133 b} administer additional doses of 12.5–25 mg every 4–6 hours if necessary;^{100 117 133 b} reduce dosage of analgesics and barbiturates accordingly.¹¹⁷

Hemolytic Disease of the Newborn†

Oral

3.7–5 mg/kg daily (given to the nearest 25-mg multiple) has been given initially in 4 divided doses after the first trimester or the 16th week of gestation in Rh-sensitized pregnant women.^a In extremely severe cases, maintenance dosage as high as 6.5 mg/kg daily has been used.^a

Prescribing Limits

Pediatric Patients

Common Cold

Oral

Maximum 9.36 mg in 24 hours for children 2 to <6 years of age.¹²⁸ (See Pediatric Use under Cautions.)

Maximum 18.75 mg in 24 hour for children 6 to <12 years of age.¹²⁸

Maximum 37.5 mg in 24 hours for children ≥12 years of age.^{128 129}

Adults

Common Cold

Oral

Maximum 37.5 mg in 24 hours.^{128 129}

Sedation

Sedation in Obstetric Patients

IM or IV

Maximum 100 mg during a 24-hour period of labor.¹¹⁷

Special Populations

Geriatric Patients

Use caution in dosage selection.¹³³ Parenteral dosage should be reduced.¹¹⁷

Cautions for Promethazine Hydrochloride

Contraindications

• 
  

  Pediatric patients <2 years of age.^{117 132 133 134 135 136} (See Boxed Warning.)

  
  


• 
  

  Concomitant administration of large doses of other CNS depressants.^a (See Specific Drugs under Interactions.)

  
  


• 
  

  Comatose patients.^{100 117 133 136}

  
  


• 
  

  Known hypersensitivity or idiosyncrasy to promethazine or other phenothiazines.^{100 117 133 136}

  
  


• 
  

  Treatment of lower respiratory symptoms (e.g., asthma).^{100 133 136}

  
  


• 
  

  FDA states that sub-Q or intra-arterial injection is contraindicated.^{139 140} (See Precautions Associated with Parenteral Administration under Cautions.)

  
  


• 
  

  Some manufacturers state that promethazine also is contraindicated in patients with bone marrow depression, angle-closure glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction;^{136 a b} others state that the drug be used with caution in these patients.^{100 117 133}

  
  

Warnings/Precautions

Warnings

Nervous System Effects

Possible impairment of ability to perform activities requiring mental alertness or physical coordination (e.g., operating machinery, driving a motor vehicle).^{100 117 133 136}

Possible extrapyramidal reactions^{117 129 134} with high doses.^{117 129}

Possible increased severity of seizures in epileptic patients; use with caution, if at all, in patients with seizure disorders.^{100 117 133 136 a}

Possible neuroleptic malignant syndrome (NMS), characterized by hyperpyrexia, muscle rigidity, altered mental status, evidence of autonomic instability (e.g., irregular pulse or BP, tachycardia, diaphoresis, cardiac dysrhythmias).^{117 133 134 136} Immediately discontinue therapy and initiate supportive and symptomatic therapy if NMS develops.^{117 133}

Respiratory Effects

Possible fatal respiratory depression.^{117 133 134 135 136}

Possible suppression of cough reflex.^a

Use with caution in patients who are having an asthmatic attack and in those with acute or chronic respiratory impairment (e.g., COPD), particularly children.^{136 a b} (See Pediatric Use under Cautions.)

Use with caution, if at all, in patients with a history of sleep apnea.^{100 117 119 124 133 136}

Hematologic Effects

Possible leukopenia, agranulocytosis, and thrombocytopenic purpura.^{117 a}

Precautions Associated with Parenteral Administration

Severe chemical irritation and damage to tissues (e.g., burning, pain, erythema, swelling, severe spasm of distal vessels, thrombophlebitis, venous thrombosis, phlebitis, abscesses, tissue necrosis, gangrene) may occur with administration of the injection, regardless of the route of administration.^{30 31 117 139 140 141 142 143 144}

Because IV administration has been associated with severe tissue injury, including gangrene requiring amputation, FDA states that deep IM injection is the preferred method for administration.^{139 140}

Possible irritation and damage from perivascular extravasation, unintentional intra-arterial injection, and intraneuronal or perineuronal infiltration.^{30 31 117 139 140 141 142}

Possible nerve damage (ranging from temporary sensory loss to palsies and paralysis).^{117 139} Injection near or into a nerve may result in permanent tissue damage.¹¹⁷ Surgical intervention (e.g., fasciotomy, skin graft, amputation) may be needed.^{117 139 140 141 144}

Possible severe chemical irritation following unintentional intra-arterial administration; may result in impairment of circulation and gangrene requiring amputation.¹¹⁷

If IV administration is required, use extreme care when administering IV; avoid extravasation or unintentional intra-arterial injection.¹¹⁷ (See IV Administration under Dosage and Administration.)

FDA states that sub-Q or intra-arterial administration of promethazine hydrochloride is contraindicated.^{139 140} Intra-arterial administration may cause chemical irritation that may be severe and cause severe arteriospasm, possibly resulting in impairment of circulation and gangrene requiring amputation.¹¹⁷

Because promethazine discolors blood on contact; aspiration of dark blood at the site of injection does not rule out the possibility of intra-arterial placement of the needle.¹¹⁷

During IV administration, observe for signs and symptoms of potential tissue injury, including burning or pain at the site of injection, phlebitis, swelling, and blistering; inform patients that adverse effects may occur immediately (i.e., while receiving the injection) or may develop hours to days after an injection of promethazine.¹³⁹

Immediately stop injection if pain at the injection site occurs during presumed IV injection; evaluate the possibility of intra-arterial placement of the needle or perivascular extravasation.^{117 139}

Sympathetic block and administration of heparin may be used for acute management of extravasation or inadvertent intra-arterial injection.¹¹⁷

Hepatic Effects

Possible obstructive jaundice; usually reversible following discontinuance of therapy.^{100 117}

Possible cholestatic jaundice.^{117 133}

Sensitivity Reactions

Dermatologic and Sensitivity Reactions

Possible photosensitivity; further therapy may be contraindicated if this effect develops.^{133 a b}

Possible urticaria, dermatitis, dermatologic reactions, and angioedema.^{117 134 136}

Sulfite Sensitivity

Some commercially available formulations of promethazine injection may contain sulfites, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.^{117 a b}

General Precautions

Cardiovascular Effects

Possible tachycardia, bradycardia, and faintness with parenteral use.¹¹⁷

Rapid IV administration may produce a transient fall in BP; administer slowly.^a

Use with caution in patients with cardiovascular disease.^{100 117 133 a b}

Possible increased BP; administer with extreme caution, if at all, to patients in hypertensive crisis.^{a b}

Other Precautions

Shares the toxic potentials of antihistamines and phenothiazines; observe the usual precautions of these agents.^{a b}

Use of Fixed Combination

When used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the concomitant agents.

Specific Populations

Pregnancy

Category C.^{100 117 133}

Lactation

Not known whether promethazine is distributed into milk.^{100 117 133} Discontinue nursing or the drug.^{117 133}

Pediatric Use

Use of promethazine is contraindicated in pediatric patients <2 years of age, because of risk of developing potentially fatal respiratory depression.^{117 132 133 134 135 136} (See Boxed Warning.)

Excessively high dosages may cause sudden death in pediatric patients.^{117 133} Possible cardiac arrest, hallucinations, oversedation, agitation, dystonic reactions, apnea, dermatologic reactions, neuroleptic malignant syndrome, and seizures with therapeutic doses and overdosage.^{117 133 134}

Use with caution in pediatric patients ≥2 years of age.^{117 133 134 135 136}

Avoid concomitant use with other respiratory depressant drugs in children ≥2 years of age, because respiratory depression and death may occur.¹³³

In children ≥2 years of age, the drug may be used for prolonged vomiting of known etiology; use not recommended in children with vomiting of unknown etiology.^{117 133 136}

Possible increased susceptibility to dystonias in acutely ill or dehydrated children; use not recommended in these children.^{133 a}

Avoid use in children ≥2 years of age with signs and symptoms suggestive of Reye’s syndrome^{117 133} or other hepatic disease.^{117 133}

Use not recommended in children ≥2 years of age with asthma, liver disease, seizure disorder, or glaucoma, unless otherwise directed by a clinician.^{128 136 b}

Possible sleep apnea and sudden infant death syndrome (SIDS) in infants and young children.^{119 123} (See Respiratory Effects under Cautions.) Use with caution in children with a history of sleep apnea, those with a family history of SIDS, and those who are less prone than usual to spontaneous arousal from sleep.^{100 123 124 a b}

Possible marked drowsiness that may be potentiated by other CNS depressants (e.g., sedatives, tranquilizers); use these drugs only under the direction of a clinician.^{133 136 a} (See Nervous System Effects under Cautions.)

Possible increased risk of CNS stimulant effects; close supervision recommended for children performing hazardous activities (e.g., bike riding).^{100 133 a}

Geriatric Use

Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults.¹³³

Increased risk of sedative effects and confusion.^{117 133} Select dosage with caution (usually starting at low end of dosage range) because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.¹³³ Dosage of the injection should be reduced.¹¹⁷

Close observation recommended.^d

Hepatic Impairment

Use with caution.^{100 117 133 a b}

Common Adverse Effects

Pronounced sedative effects, drowsiness, confusion, disorientation.^{100 117 133 136}

Interactions for Promethazine Hydrochloride

Specific Drugs and Laboratory Tests

Drug or Test	Interaction	Comments
CNS depressants	Additive effects100 117 133 136	Either avoid concomitant use or reduce barbiturate dosage by ≥50% and narcotic dosage by 25–50% if administered concomitantly117 133
Epinephrine	Reversal of vasopressor effect of epinephrine133	Administer norepinephrine or phenylephrine if a vasopressor agent is required; epinephrine should not be used117
Anticholinergic agents	Additive anticholinergic effects 133	Use with caution117 133
MAO inhibitors	Increased extrapyramidal effects117 133
Immunologic urinary pregnancy tests	Possible test interference: false-positive Gravindex test and false-negative Prepurex and Dap test100 133 a

Promethazine Hydrochloride Pharmacokinetics

Absorption

Bioavailability

Well absorbed from the GI tract^{100 133} and from parenteral sites.^{117 a b}

Onset

Onset of sedative effects occurs within 20 minutes following oral, rectal, or IM administration;^{100 117 133 a b} following IV administration, sedative effects occur within 3–5 minutes.^{117 a b}

Duration

Duration of sedative effects usually about 2–8 hours^{117 133 a b} (depending on the dose and route of administration);^{a b} effects may persist for 12 hours.^{100 117 133}

Distribution

Extent

Widely distributed in body tissues.^{a b}

Compared with other organs, lower concentrations of the drug are found in the brain, but this concentration is higher than the plasma concentration.^{a b}

Readily crosses the placenta.^{115 116 a b}

It is not known if promethazine is distributed into milk.^{100 117 133 a b}

Plasma Protein Binding

93% protein bound (determined by gas chromatography)¹²⁶ and 76–80% bound (determined by high-performance liquid chromatography).¹²⁵

Elimination

Metabolism

Metabolized in the liver.^{100 117 133 a b}

Elimination Route

Excreted slowly in urine (mainly) and feces, principally as inactive promethazine sulfoxide and glucuronides.^{100 117 133 a b}

Half-life

9–16 hours (following IV use) and about 9.8 hours (following IM use).¹¹⁷

Stability

Storage

Oral

Tablets

Tight, light-resistant containers at 20–25°C.¹³³ Protect from light.¹³³

Solution

Tight, light-resistant containers at 15–30°C.¹⁰⁰ Protect from light.¹⁰⁰ Avoid freezing.^a

Parenteral

Injection

Tight, light-resistant containers preferably at 20–25°C (may be exposed to 15–30°C).¹¹⁷

Rectal

Suppositories

Well-closed containers at 2–8°C.¹³³ Protect from light.¹³³

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Compatible
Dextran 6% in dextrose 5%
Dextran 6% in sodium chloride 0.9%
Dextrose–Ringer’s injection combinations
Dextrose–Ringer’s injection, lactated, combinations
Dextrose–saline combinations
Dextrose 2½, 5, or 10% in water
Fructose 10% in sodium chloride 0.9%
Fructose 10% in water
Invert sugar 5 and 10% in sodium chloride 0.9%
Invert sugar 5 and 10% in water
Ionosol products
Ringer’s injection
Ringer’s injection, lactated
Sodium chloride 0.45 or 0.9%
Sodium lactate (1/6)M

Drug Compatibility

Admixture CompatibilityHID

Compatible
Amikacin sulfate
Ascorbic acid injection
Chloroquine phosphate
Hydromorphone HCl
Vitamin B complex with C
Incompatible
Aminophylline
Chloramphenicol sodium succinate
Chlorothiazide sodium
Furosemide
Heparin sodium
Hydrocortisone sodium succinate
Methohexital sodium
Penicillin G sodium
Pentobarbital sodium
Phenobarbital sodium
Thiopental sodium
Variable
Penicillin G potassium

Y-Site CompatibilityHID

Compatible
Amifostine
Amsacrine
Aztreonam
Bivalirudin
Ciprofloxacin
Cisplatin
Cladribine
Cyclophosphamide
Cytarabine
Dexmedetomidine HCI
Docetaxel
Doxorubicin HCl
Etoposide phosphate
Fenoldopam mesylate
Filgrastim
Fluconazole
Fludarabine phosphate
Gemcitabine HCl
Granisetron HCl
Hetastarch in lactated electrolyte injection (Hextend)
Linezolid
Melphalan HCl
Ondansetron HCl
Oxaliplatin
Pemetrexed disodium
Remifentanil HCl
Sargramostim
Teniposide
Thiotepa
Vinorelbine tartrate
Incompatible
Aldesleukin
Allopurinol sodium
Amphotericin B cholesteryl sulfate complex
Cefepime HCl
Doxorubicin HCl liposome injection
Foscarnet sodium
Lansoprazole
Methotrexate sodium
Piperacillin sodium–tazobactam sodium
Variable
Cefazolin sodium
Ceftizoxime sodium
Heparin sodium
Hydrocortisone sodium succinate
Potassium chloride
Vitamin B complex with C

ActionsActions

• 
  

  Blocks H₁-receptor sites,^{100 117 133} but does not block release of histamine.¹¹⁷

  
  


• 
  

  Produces either CNS stimulation or CNS depression (sedation); CNS depression is more common with therapeutic doses.^{134 136 a b}

  
  


• 
  

  Exhibits antiemetic, anticholinergic, and local anesthetic effects; also exhibits antimotion sickness action.^{100 117 133 134 136 a b}

  
  


• 
  

  Precise mechanism of the CNS effects unknown.^{a b} Antimotion sickness action apparently related to central anticholinergic effects.^a

  
  


• 
  

  Slight antitussive activity may result from anticholinergic and CNS-depressant effects.^a

  
  


• 
  

  Inhibits collagen-induced platelet aggregation in neonates whose mothers had received the drug during labor.¹⁰¹

  
  


• 
  

  Inhibits the ability of fetal macrophages to bind Rh-positive erythrocytes.^{106 107}

  
  


• 
  

  Inhibits phagocytosis and hexose monophosphate shunt activity in polymorphonuclear leukocytes.¹⁰⁸

  
  


• 
  

  Inhibits lysis of fetal Rh-positive erythrocytes mediated by lymphocytes and polymorphonuclear leukocytes.¹⁰⁹

  
  


• 
  

  Stabilizes the erythrocyte membrane against hemolysis.^{109 a}

  
  

Advice to Patients

• 
  

  Importance of informing parents and caregivers that promethazine should not be used in pediatric patients <2 years of age.^{134 135 136}

  
  


• 
  

  Importance of informing parents and caregivers to use the drug with caution and obtain a clinician's advice about administration of any promethazine dosage form in pediatric patients ≥2 years of age.¹³⁶

  
  


• 
  

  Risk of drowsiness; avoid alcohol and other CNS depressants and use caution when driving, operating machinery, or engaging in other hazardous tasks.^{100 117 133 136}

  
  


• 
  

  Importance of informing caregivers that pediatric patients performing hazardous activities (e.g., bike riding) should be closely supervised, because children may be at increased risk for experiencing CNS stimulant effects.^{100 117 133}

  
  


• 
  

  Importance of informing clinicians of any involuntary muscle movements or unusual sensitivity to sunlight.^{100 117 133}

  
  


• 
  

  Importance of avoiding prolonged exposure to sun.^{117 133}

  
  


• 
  

  Importance of promptly informing clinicians of any pain at the injection site during IV injection or other symptoms (e.g., erythema, swelling, blistering) occurring within days of IV injection.^{117 139}

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.^{117 133 136}

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{117 133 136 a}

  
  


• 
  

  Importance of informing patients of other important precautionary information.^{117 133} (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Promethazine Hydrochloride

Routes

primidone

PRIM-i-done

Commonly used brand name(s)

In the U.S.

• Mysoline

Available Dosage Forms:

• Tablet


• Suspension

Therapeutic Class: Anticonvulsant

Pharmacologic Class: Barbiturate, Intermediate Acting

Uses For primidone

Primidone is used alone or in combination with other medicines, to control seizures (convulsions) in the treatment of epilepsy. primidone is an anticonvulsant that works in the brain tissue to stop seizures.

primidone is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, primidone is used in certain patients with the following medical conditions:

• Essential tremor.

Before Using primidone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For primidone, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to primidone or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of primidone in children.

Geriatric

No information is available on the relationship of age to the effects of primidone in geriatric patients.

Unusual excitement or restlessness may occur in elderly patients, who are usually more sensitive than younger adults to these effects of primidone.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking primidone, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using primidone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adinazolam


• Alprazolam


• Amobarbital


• Anisindione


• Aprobarbital


• Bromazepam


• Brotizolam


• Butabarbital


• Butalbital


• Carisoprodol


• Chloral Hydrate


• Chlordiazepoxide


• Chlorzoxazone


• Clobazam


• Clonazepam


• Clorazepate


• Dantrolene


• Diazepam


• Dicumarol


• Estazolam


• Ethchlorvynol


• Flunitrazepam


• Flurazepam


• Halazepam


• Ketazolam


• Lorazepam


• Lormetazepam


• Medazepam


• Mephenesin


• Mephobarbital


• Meprobamate


• Metaxalone


• Methocarbamol


• Methohexital


• Midazolam


• Nitrazepam


• Nordazepam


• Oxazepam


• Pentobarbital


• Phenindione


• Phenobarbital


• Phenprocoumon


• Prazepam


• Primidone


• Quazepam


• Quetiapine


• Secobarbital


• Sodium Oxybate


• Temazepam


• Thiopental


• Triazolam


• Valproic Acid

Using primidone with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Betamethasone


• Cannabis


• Carbamazepine


• Cortisone


• Desogestrel


• Dexamethasone


• Dienogest


• Drospirenone


• Estradiol Cypionate


• Estradiol Valerate


• Ethinyl Estradiol


• Ethynodiol Diacetate


• Etonogestrel


• Ginkgo


• Hydrocortisone


• Lamotrigine


• Leucovorin


• Levonorgestrel


• Medroxyprogesterone Acetate


• Mestranol


• Methylprednisolone


• Norelgestromin


• Norethindrone


• Norgestimate


• Norgestrel


• Prednisolone


• Prednisone


• Rufinamide


• Tiagabine


• Triamcinolone


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using primidone with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use primidone, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Problems

The presence of other medical problems may affect the use of primidone. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma, emphysema, or chronic lung disease—Primidone may cause serious problems in breathing.

• Depression, history of or


• Hyperactivity (in children) or


• Kidney disease or


• Liver disease—Primidone may make these conditions worse.

• Porphyria (an enzyme problem)—Should not be used in patients with this condition.

Proper Use of primidone

Take primidone only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

primidone may be used with other seizure medicines. Keep using all of your seizure medicines unless your doctor tells you to stop.

Take primidone everyday in regularly spaced doses as ordered by your doctor. This will provide the proper amount of medicine needed to prevent seizures.

Dosing

The dose of primidone will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of primidone. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (chewable tablets, suspension, or tablets):
  
  • For seizures:
    
    • Adults, teenagers, and children 8 years of age or older—At first, 100 or 125 milligrams (mg) once a day at bedtime. Your doctor may increase your dose if needed. However, the dose is usually not more than 2000 mg a day.
    
    
    • Children up to 8 years of age—At first, 50 mg once a day at bedtime. Your doctor may increase your dose if needed.
    
    
  
  

Missed Dose

If you miss a dose of primidone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using primidone

It is very important that your doctor check your progress at regular visits while you are using primidone to see if it is working properly and to allow for a change in the dose. Blood tests may be needed to check for any unwanted effects.

Using primidone while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

If you have been taking primidone regularly for several weeks, you should not suddenly stop taking it without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping completely.

primidone may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. If you, your child, or your caregiver notice any of these side effects, tell your doctor or your child's doctor right away.

Before you have any medical tests, tell the medical doctor in charge that you are taking primidone. The results of some tests (such as the metyrapone and phentolamine tests) may be affected by primidone.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are using primidone.

primidone will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using primidone.

Primidone may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to primidone before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Oral contraceptives (birth control pills) containing estrogen may not work properly if you take them while you are taking primidone. Unplanned pregnancies may occur. You should use a different or additional means of birth control while you are taking primidone. If you have any questions about this, check with your doctor.

primidone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Shakiness and unsteady walk


• unsteadiness, trembling, or other problems with muscle control or coordination

Less common

• Unusual excitement or restlessness (especially in children and in the elderly)

Rare

• Chills


• cough or hoarseness


• fainting spells


• fever and sore throat


• fever with or without chills


• general feeling of tiredness or weakness


• irregular heartbeat


• lower back or side pain


• painful or difficult urination


• pale skin


• shortness of breath


• skin rash


• sores, ulcers, or white spots on the lips or in the mouth


• unusual bleeding or bruising


• unusual tiredness or weakness

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Confusion


• continuous, uncontrolled rolling eye movements


• double vision


• troubled breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Clumsiness or unsteadiness


• dizziness or lightheadedness


• feeling of constant movement of self or surroundings


• sensation of spinning

Less common

• Decreased sexual ability


• drowsiness


• loss of appetite


• mood or mental changes


• nausea or vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: primidone side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More primidone resources

• Primidone Side Effects (in more detail)
• Primidone Use in Pregnancy & Breastfeeding
• Drug Images
• Primidone Drug Interactions
• Primidone Support Group
• 15 Reviews for Primidone - Add your own review/rating

• primidone Concise Consumer Information (Cerner Multum)


• Primidone Prescribing Information (FDA)


• Primidone Monograph (AHFS DI)


• Primidone Professional Patient Advice (Wolters Kluwer)


• Primidone MedFacts Consumer Leaflet (Wolters Kluwer)


• Mysoline Prescribing Information (FDA)

Compare primidone with other medications

• Benign Essential Tremor
• Seizures

Primaxin IV

Pronunciation: IM-i-PEN-em/SYE-la-STAT-in
Generic Name: Imipenem/Cilastatin
Brand Name: Primaxin IV

Primaxin IV is used for:

Treating infections caused by certain bacteria.

Primaxin IV is a carbapenem antibiotic. It kills bacteria by blocking growth of the bacteria's cell wall.

Do NOT use Primaxin IV if:

• you are allergic to any ingredient in Primaxin IV or any other carbapenem (eg, meropenem)


• you are taking probenecid


• the patient is a child with a brain or nervous system infection, or weighs less than 66 lb (30 kg) and has kidney problems

Contact your doctor or health care provider right away if any of these apply to you.

Before using Primaxin IV:

Some medical conditions may interact with Primaxin IV. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a penicillin antibiotic (eg, amoxicillin) or cephalosporin antibiotic (eg, cephalexin)


• if you have kidney problems, a history of seizures or central nervous system problems (eg, brain lesions), or you are in shock


• if you are on dialysis

Some MEDICINES MAY INTERACT with Primaxin IV. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Ganciclovir because risk of seizures may be increased


• Probenecid because actions and side effects of Primaxin IV may be increased


• Divalproex sodium or valproic acid because their effectiveness may be decreased by Primaxin IV


• Other medicines that may increase your risk of seizures (eg, tramadol) because the risk of seizures may be further increased when combined with Primaxin IV. Ask your doctor or pharmacist if you have questions about whether any of your other medicines may increase your risk of seizures

This may not be a complete list of all interactions that may occur. Ask your health care provider if Primaxin IV may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Primaxin IV:

Use Primaxin IV as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Primaxin IV is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Primaxin IV at home, a health care provider will teach you how to use it. Be sure you understand how to use Primaxin IV. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.


• Do not use Primaxin IV if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.


• To clear up your infection completely, use Primaxin IV for the full course of treatment. Keep using it even if you feel better in a few days.


• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.


• If you miss a dose of Primaxin IV, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Primaxin IV.

Important safety information:

• Primaxin IV may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Primaxin IV. Using Primaxin IV alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.


• Do not use more than the recommended dose or more often than prescribed without checking with your doctor.


• Be sure to use Primaxin IV for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Primaxin IV only works against bacteria; it does not treat viral infections (eg, the common cold).


• Mild diarrhea is common with antibiotic use. However, a more serious form of diarrhea (pseudomembranous colitis) may rarely occur. This may develop while you use the antibiotic or within several months after you stop using it. Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor.


• Long-term or repeated use of Primaxin IV may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Tell your doctor or dentist that you take Primaxin IV before you receive any medical or dental care, emergency care, or surgery.


• Lab tests, including kidney function, liver function, and blood counts, may be performed to monitor your progress. Be sure to keep all doctor and lab appointments.


• Use Primaxin IV with caution in the ELDERLY; they may be more sensitive to its effects.


• Use Primaxin IV with extreme caution in CHILDREN younger than 10 years old who have diarrhea or an infection of the stomach or bowel.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Primaxin IV while you are pregnant. It is not known if Primaxin IV is found in breast milk. If you are or will be breast-feeding while you use Primaxin IV, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Primaxin IV:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Mild diarrhea; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; breathing problems; chest pain; dark urine; decreased urination; fast or irregular heartbeat; fever, chills, or sore throat; hearing loss; joint pain or tenderness; mental or mood changes (eg, agitation, anxiety, confusion); numbness or tingling of the skin; pain, swelling, or redness at the injection site; red, swollen, blistered, or peeling skin; seizures; severe diarrhea; severe stomach cramps or pain; shortness of breath; swelling of the hands or feet; tremors or abnormal muscle movements; unusual bruising or bleeding; unusual tiredness or weakness; unusual vaginal odor or discharge; vein swelling or tenderness; white patches in the mouth; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Primaxin IV side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include seizures; slow breathing; tremors.

Proper storage of Primaxin IV:

Primaxin IV is usually handled and stored by a health care provider. If you are using Primaxin IV at home, store Primaxin IV as directed by your pharmacist or health care provider. Keep Primaxin IV out of the reach of children and away from pets.

General information:

• If you have any questions about Primaxin IV, please talk with your doctor, pharmacist, or other health care provider.


• Primaxin IV is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Primaxin IV. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Primaxin IV resources

• Primaxin IV Side Effects (in more detail)
• Primaxin IV Use in Pregnancy & Breastfeeding
• Primaxin IV Drug Interactions
• Primaxin IV Support Group
• 0 Reviews for Primaxin IV - Add your own review/rating

• Primaxin IV Advanced Consumer (Micromedex) - Includes Dosage Information


• Primaxin IV Concise Consumer Information (Cerner Multum)


• Primaxin IV Prescribing Information (FDA)


• Imipenem-Cilastatin Professional Patient Advice (Wolters Kluwer)


• Primaxin IM Prescribing Information (FDA)

Compare Primaxin IV with other medications

• Aspiration Pneumonia
• Bacteremia
• Bacterial Infection
• Bone infection
• Bronchitis
• Deep Neck Infection
• Endocarditis
• Endometritis
• Febrile Neutropenia
• Intraabdominal Infection
• Joint Infection
• Kidney Infections
• Meningitis
• Nosocomial Pneumonia
• Pelvic Infections
• Peritonitis
• Pneumonia
• Pneumonia with Cystic Fibrosis
• Septicemia
• Skin and Structure Infection
• Skin Infection
• Urinary Tract Infection

Proctosol-HC cream, ointment, suppository

Generic Name: hydrocortisone rectal (cream, ointment, suppository) (hye dro KORT i zone REK tal)

Brand Names: Anucort-HC, Anumed-HC, Anusol-HC, Cortizone-10 Anal Itch Cream, Hemorrhoidal HC, Hemril-30, Hemril-HC Uniserts, Preparation H Hydrocortisone, Procto-Kit 1%, Procto-Kit 2.5%, Procto-Pak 1%, Proctocort, Proctocream-HC, Proctosert HC, Proctosol-HC, Proctozone HC, Proctozone-H, Recort Plus, Rectasol-HC, Tucks HC

What is hydrocortisone rectal?

Hydrocortisone is a steroid medicine that reduces inflammation in the body.

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Hydrocortisone rectal is used to treat itching or swelling caused by hemorrhoids or other inflammatory conditions of the rectum or anus.

Hydrocortisone rectal is also used together with other medications to treat ulcerative colitis, proctitis, and other inflammatory conditions of the lower intestines and rectal area.

Hydrocortisone rectal may also be used for purposes not listed in this medication guide.

What is the most important information I should know about hydrocortisone rectal?

The information in this medication guide is specific to hydrocortisone rectal cream, ointment, or suppository.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Call your doctor at once if you have any bleeding from your rectum, feeling short of breath (even with mild exertion), swelling of your ankles or feet, or rapid weight gain.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

What should I discuss with my health care provider before using hydrocortisone rectal?

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• 
  

  congestive heart failure;

  
  


• 
  

  a history of tuberculosis;

  
  


• 
  

  stomach ulcer or diverticulitis;

  
  


• 
  

  a colostomy or ileostomy;

  
  


• 
  

  fever or any type of infection;

  
  


• 
  

  kidney disease;

  
  


• 
  

  high blood pressure; or

  
  


• 
  

  myasthenia gravis.

  
  

Also tell your doctor if you have diabetes. Steroid medicines may increase the glucose (sugar) levels in your blood or urine. You may also need to adjust the dose of your diabetes medications.

FDA pregnancy category C. It is not known whether hydrocortisone rectal will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether hydrocortisone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use hydrocortisone rectal?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not take hydrocortisone rectal by mouth. It is for use only in your rectum.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. You may need to use this medication for up to 8 weeks.

Wash your hands before and after using this medicine.

Try to empty your bowel and bladder just before using hydrocortisone rectal.

Remove the outer wrapper from the suppository before inserting it. Avoid handling the suppository too long or it will melt in your hands. The rectal suppository can stain clothing or other fabrics it comes into contact with.

For best results from the suppository, lie down after inserting it and hold in the suppository. The suppository will melt quickly once inserted and you should feel little or no discomfort while holding it in.

For best results from the cream, use only the applicator provided with the medication. Otherwise, follow the directions provided with your rectal cream.

Avoid using the bathroom for one to three hours after inserting the cream or suppository.

Apply the ointment to the rectum and surrounding skin of the rectal area as directed on the package label.

Call your doctor if your symptoms do not improve or if they get worse after using this medicine for a few days.

Store the rectal cream at room temperature away from moisture and heat. Store the rectal suppositories at cool room temperature away from moisture and heat. Do not refrigerate or freeze them.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

An overdose of hydrocortisone rectal is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

What should I avoid while using hydrocortisone rectal ?

Avoid getting a vaccine during your treatment with hydrocortisone rectal. Vaccines may not work as well while you are using a steroid medicine.

Hydrocortisone rectal side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

• 
  

  feeling short of breath, even with mild exertion;

  
  


• 
  

  swelling of your ankles or feet;

  
  


• 
  

  muscle weakness;

  
  


• 
  

  rapid weight gain, especially in your face and midsection;

  
  


• 
  

  severe rectal pain or burning;

  
  


• 
  

  bleeding from your rectum;

  
  


• 
  

  severe stomach pain;

  
  


• 
  

  sudden and severe headache or pain behind your eyes; or

  
  


• 
  

  seizure (convulsions).

  
  

Less serious side effects may include:

• 
  

  mild rectal pain or burning;

  
  


• 
  

  acne;

  
  


• 
  

  changes in your menstrual periods;

  
  


• 
  

  increased sweating; or

  
  


• 
  

  increased facial or body hair growth.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect hydrocortisone rectal ?

Before using hydrocortisone rectal, tell your doctor if you also use insulin or take oral diabetes medication.

There may be other drugs that can interact with hydrocortisone rectal. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Proctosol-HC resources

• Proctosol-HC Side Effects (in more detail)
• Proctosol-HC Use in Pregnancy & Breastfeeding
• Proctosol-HC Drug Interactions
• Proctosol-HC Support Group
• 2 Reviews for Proctosol-HC - Add your own review/rating

Compare Proctosol-HC with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Hemorrhoids
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Ulcerative Colitis, Active

Where can I get more information?

• Your pharmacist can provide more information about hydrocortisone rectal cream, ointment, or suppository.

See also: Proctosol-HC side effects (in more detail)

Profilnine SD

Generic Name: factor IX complex (FAK tor NINE KOM plex)

Brand Names: Bebulin VH, Konyne 80, Profilnine SD, Proplex T

What is Profilnine SD (factor IX complex)?

Factor IX (nine) is a naturally occurring protein in the blood that helps blood to clot. A lack of clotting factors can cause uncontrolled bleeding, as the blood is unable to clot properly.

Factor IX complex is a combination of four different clotting factors and other proteins. This medication works by temporarily raising levels of these clotting factors in the blood to aid in clotting.

Factor IX complex is used to treat or prevent bleeding episodes in people with hemophilia B. It is also used to control bleeding related to surgery or dentistry in people with hemophilia B.

Factor IX may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Profilnine SD (factor IX complex)?

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX or factor VIII (eight) deficiency.

Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder.

Factor IX complex is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

What should I discuss with my healthcare provider before using Profilnine SD (factor IX complex)?

Before using factor IX complex, your specific blood clotting disorder must be diagnosed as factor IX or factor VIII (eight) deficiency.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether factor IX complex passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Factor IX complex is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Your doctor may want you to receive a hepatitis vaccination before you start using factor IX complex.

How should I use Profilnine SD (factor IX complex)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label. Always check the strength of the medicine on the label to be sure you are using the correct potency.

Factor IX complex is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

Always wash your hands before preparing and giving your injection.

Factor IX complex must be mixed with a liquid (diluent) before injecting it. If you store your medicine in the refrigerator, take a medicine and diluent vial out of the refrigerator and allow each to warm to room temperature before mixing them. Do not heat the medicine or diluent.

After mixing, gently swirl the mixture and allow the medicine to completely dissolve.

After mixing the medicine and diluent, the mixture should be kept at room temperature and must be used within 3 hours. Do not put mixed medicine into the refrigerator.

Draw your dose into a syringe only when you are ready to give yourself an injection. Each vial is for one use only. After measuring your dose, throw the vial away, even if there is medicine left in it.

Do not use this medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

Check your pulse before and during your injection. If your pulse rate changes, slow or stop the injection until your pulse rate returns to normal.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Carry an ID card or wear a medical alert bracelet stating that you have hemophilia in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you have a bleeding or blood-clotting disorder. Store the medication and the diluent in the refrigerator and do not allow them to freeze.

Throw away any leftover medicine and diluent if the expiration date has passed.

What happens if I miss a dose?

Factor IX is sometimes used only as needed, so you may not be on a dosing schedule. If you are using the medication regularly, use the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Call your doctor if you think you have used too much of this medicine. An overdose of factor IX complex is not expected to produce life-threatening symptoms.

What should I avoid while using Profilnine SD (factor IX complex)?

Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using factor IX complex.

Profilnine SD (factor IX complex) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; nausea, vomiting; feeling light-headed, fainting; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

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  cough, chest pain;

  
  


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  weak or shallow breathing;

  
  


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  feeling short of breath;

  
  


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  headache, feeling like you might pass out;

  
  


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  fever, chills, drowsiness, and runny nose followed by skin rash and joint pain 2 weeks later;

  
  


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  nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  
  


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  easy bruising, increased bleeding episodes; or

  
  


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  bleeding from a wound or where the medicine was injected.

  
  

Less serious side effects may include:

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  mild nausea or stomach pain; or

  
  


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  mild tingly or jittery feeling.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Profilnine SD (factor IX complex)?

There may be other drugs that can affect factor IX complex. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More Profilnine SD resources

• Profilnine SD Side Effects (in more detail)
• Profilnine SD Use in Pregnancy & Breastfeeding
• Profilnine SD Drug Interactions
• Profilnine SD Support Group
• 0 Reviews for Profilnine SD - Add your own review/rating

• Profilnine SD Prescribing Information (FDA)


• Profilnine SD Advanced Consumer (Micromedex) - Includes Dosage Information


• Profilnine SD MedFacts Consumer Leaflet (Wolters Kluwer)


• Bebulin VH Prescribing Information (FDA)

Compare Profilnine SD with other medications

• Factor IX Deficiency
• Factor VII Deficiency
• Hemophilia A with Inhibitors
• Hemophilia B

Where can I get more information?

• Your doctor or pharmacist can provide more information about factor IX.

See also: Profilnine SD side effects (in more detail)