Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED DimenhyDRINATE Injection, USP, 50 mg/mL is available in multiple dose amber vials, as follows: Product Code Unit of Sale Strength Each 361601 NDC 63323-366-01 Unit of 25 50 mg per mL NDC 63323-366-00 1 mL in a 2 mL multiple dose vial Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.; PACKAGE LABEL - PRINCIPAL DISPLAY - Dimenhydrinate 1 mL Vial Label NDC 63323-366-00 361601 DimenhyDRINATE INJECTION, USP 50 mg per mL For IM Use For IV Use: See package insert. Rx only 1 mL Multiple Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Dimenhydrinate 1 mL Vial Tray Label NDC 63323-366-01 361601 DimenhyDRINATE INJECTION, USP 50 mg per mL For IM Use *For IV Use Rx only 25 x 1 mL Multiple Dose Vials dimen-label-01.jpg dimen-label-02.jpg
- HOW SUPPLIED DimenhyDRINATE Injection, USP, 50 mg/mL is available in multiple dose amber vials, as follows: Product Code Unit of Sale Strength Each 361601 NDC 63323-366-01 Unit of 25 50 mg per mL NDC 63323-366-00 1 mL in a 2 mL multiple dose vial Protect from light. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.
- PACKAGE LABEL - PRINCIPAL DISPLAY - Dimenhydrinate 1 mL Vial Label NDC 63323-366-00 361601 DimenhyDRINATE INJECTION, USP 50 mg per mL For IM Use For IV Use: See package insert. Rx only 1 mL Multiple Dose Vial PACKAGE LABEL - PRINCIPAL DISPLAY - Dimenhydrinate 1 mL Vial Tray Label NDC 63323-366-01 361601 DimenhyDRINATE INJECTION, USP 50 mg per mL For IM Use *For IV Use Rx only 25 x 1 mL Multiple Dose Vials dimen-label-01.jpg dimen-label-02.jpg
Overview
Dimenhydrinate, an anti-nauseant/antiemetic, is the 8-chlorotheophylline salt of diphenhydramine. It contains not less than 53% and not more than 55.5% of diphenhydramine, and not less than 44% and not more than 47% of 8-chlorotheophylline, calculated on the dried basis. Chemically, it is 8-chlorotheophylline compound with 2(diphenylmethoxy)-N,N-dimethylethylamine (1:1), and the structural formula is: C 17 H 21 NO•C 7 H 7 ClN 4 O 2 M.W. 469.96 Dimenhydrinate Injection, USP contains a sterile solution of Dimenhydrinate 50 mg/mL; Propylene Glycol 50%; Benzyl Alcohol 5% as preservative; and Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH. structure
Indications & Usage
Dimenhydrinate Injection, USP is indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness.
Dosage & Administration
Dimenhydrinate in the injectable form is indicated when the oral form is impractical. Adults Nausea or vomiting may be expected to be controlled for approximately 4 hours with 50 mg, and prevented by a similar dose every 4 hours. Its administration may be attended by some degree of drowsiness in some patients, and 100 mg every 4 hours may be given in conditions in which drowsiness is not objectionable or is even desirable. For intramuscular administration, each milliliter (50 mg) of solution is injected as needed, but for intravenous administration, each milliliter (50 mg) of solution must be diluted in 10 mL of 0.9% Sodium Chloride Injection, USP and injected over a period of 2 minutes. Pediatric For intramuscular administration, 1.25 mg/kg of body weight or 37.5 mg/m 2 of body surface area is administered four times daily. The maximum dose should not exceed 300 mg daily (see CONTRAINDICATIONS ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Adults Nausea or vomiting may be expected to be controlled for approximately 4 hours with 50 mg, and prevented by a similar dose every 4 hours. Its administration may be attended by some degree of drowsiness in some patients, and 100 mg every 4 hours may be given in conditions in which drowsiness is not objectionable or is even desirable. For intramuscular administration, each milliliter (50 mg) of solution is injected as needed, but for intravenous administration, each milliliter (50 mg) of solution must be diluted in 10 mL of 0.9% Sodium Chloride Injection, USP and injected over a period of 2 minutes. Pediatric For intramuscular administration, 1.25 mg/kg of body weight or 37.5 mg/m 2 of body surface area is administered four times daily. The maximum dose should not exceed 300 mg daily (see CONTRAINDICATIONS ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Warnings & Precautions
WARNINGS Caution should be used when dimenhydrinate is given in conjunction with certain antibiotics that may cause ototoxicity, since dimenhydrinate is capable of masking ototoxic symptoms, and an irreversible state may be reached. This drug may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks, such as driving a vehicle or operating machinery. The concomitant use of alcohol or other central nervous system depressants may have an additive effect. Therefore, patients should be warned accordingly. Dimenhydrinate should be used with caution in patients having conditions which might be aggravated by anticholinergic therapy (i.e., prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, bladder neck obstruction, narrow-angle glaucoma, bronchial asthma, or cardiac arrhythmias). The preparation should not be injected intra-arterially. Pediatric Patients For infants and children especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young child, particularly, they may produce excitation (see CONTRAINDICATIONS ). Pediatric Patients For infants and children especially, antihistamines in overdosage may cause hallucinations, convulsions, or death. As in adults, antihistamines may diminish mental alertness in pediatric patients. In the young child, particularly, they may produce excitation (see CONTRAINDICATIONS ).
Contraindications
Neonates and patients with a history of hypersensitivity to dimenhydrinate or its components (diphenhydramine or 8-chlorotheophylline) should not be treated with dimenhydrinate. Note: This product contains Benzyl Alcohol. Benzyl Alcohol has been associated with a fatal “Gasping Syndrome” in premature infants and infants of low birth weight.
Adverse Reactions
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The most frequent adverse reaction to dimenhydrinate is drowsiness. Dizziness may also occur. Symptoms of dry mouth, nose and throat, blurred vision, difficult or painful urination, headache, anorexia, nervousness, restlessness or insomnia (especially in pediatric patients), skin rash, thickening of bronchial secretions, tachycardia, epigastric distress, lassitude, excitation, and nausea have been reported.
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