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| Product NDC Code | 63323-366 | ||||
|---|---|---|---|---|---|
| Drug Name | Dimenhydrinate |
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| Type | Generic | ||||
| Active Ingredients |
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| Route | INTRAMUSCULAR, INTRAVENOUS | ||||
| Dosage Form | INJECTION, SOLUTION | ||||
| RxCUI drug identifier | 309914 | ||||
| Application Number | ANDA040519 | ||||
| Labeler Name | Fresenius Kabi USA, LLC | ||||
| Packages |
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Overdosage of Dimenhydrinate
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.OVERDOSAGE Drowsiness is the usual clinical side effect. Convulsions, coma, and respiratory depression may occur with massive overdosage. No specific antidote is known. If respiratory depression occurs, mechanically assisted respiration should be initiated and oxygen should be administered. Convulsions should be treated with appropriate doses of diazepam. Phenobarbital (5 to 6 mg/kg) may be given to control convulsions in pediatric patients. The oral LD 50 in mice and rats is 203 mg/kg and 1320 mg/kg, respectively. The intraperitoneal LD 50 in mice is 149 mg/kg.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS 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.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY While the precise mode of action of dimenhydrinate is not known, it has a depressant action on hyperstimulated labyrinthine function.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.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.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION 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
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND 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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Dimenhydrinate Injection, USP is indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness.
Spl product data elements
Usually a list of ingredients in a drug product.Dimenhydrinate Dimenhydrinate BENZYL ALCOHOL PROPYLENE GLYCOL SODIUM HYDROXIDE HYDROCHLORIC ACID DIMENHYDRINATE CHLORTHEOPHYLLINE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PACKAGE LABEL - PRINCIPAL DISPLAY - Dimenhydrinate 1 mL Vial Label NDC 63323-366-01 361601 DimenhyDRINATE INJECTION, USP 50 mg/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/mL For IM Use *For IV Use Rx only 1 mL Multiple Dose Vial vial tray
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Rx only
45981B Revised: April 2008 logo
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 20 times the human dose, and in rabbits at doses up to 25 times the human dose (on a mg/kg basis), and have revealed no evidence of impaired fertility or harm to the fetus due to dimenhydrinate. There are no adequate and well-controlled studies in pregnant women. However, clinical studies in pregnant women have not indicated that dimenhydrinate increases the risk of abnormalities when administered in any trimester of pregnancy. It would appear that the possibility of fetal harm is remote when the drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, dimenhydrinate should be used during pregnancy only if clearly needed.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED DimenhyDRINATE Injection, USP, 50 mg/mL is available in multiple dose amber vials, as follows: Product No. NDC No. Strength Vial Size 361601 63323-366-01 50 mg/mL 1 mL in 2 mL vial, in packages of 25. 361610 63323-366-10 50 mg/mL 10 mL in a 10 mL vial, packaged individually. Protect from light. Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature]. Vial stoppers do not contain natural rubber latex.
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| 361601 | 63323-366-01 | 50 mg/mL | 1 mL in 2 mL vial, in packages of 25. |
| 361610 | 63323-366-10 | 50 mg/mL | 10 mL in a 10 mL vial, packaged individually. |
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS General Drowsiness may be experienced by some patients, especially with high dosage. This effect frequently is not undesirable in conditions for which the drug is used. Information for Patients Because of the potential for drowsiness, patients taking dimenhydrinate should be cautioned against operating automobiles or dangerous machinery (see WARNINGS ). Carcinogenesis, Mutagenesis, Impairment of Fertility Mutagenicity screening tests performed with dimenhydrinate, diphenhydramine, and 8-chlorotheophylline produced positive results in the bacterial systems and negative results in the mammalian systems. There are no human data that indicate dimenhydrinate is a carcinogen or mutagen or that it impairs fertility. Pregnancy Pregnancy Category B. Reproduction studies have been performed in rats at doses up to 20 times the human dose, and in rabbits at doses up to 25 times the human dose (on a mg/kg basis), and have revealed no evidence of impaired fertility or harm to the fetus due to dimenhydrinate. There are no adequate and well-controlled studies in pregnant women. However, clinical studies in pregnant women have not indicated that dimenhydrinate increases the risk of abnormalities when administered in any trimester of pregnancy. It would appear that the possibility of fetal harm is remote when the drug is used during pregnancy. Nevertheless, because the studies in humans cannot rule out the possibility of harm, dimenhydrinate should be used during pregnancy only if clearly needed. Labor and Delivery The safety of dimenhydrinate given during labor and delivery has not been established. Reports have indicated dimenhydrinate may have an oxytocic effect. Caution is advised when this effect is unwanted or in situations where it may prove detrimental. Nursing Mothers Small amounts of dimenhydrinate are excreted in breast milk. Because of the potential for adverse reactions in nursing infants from dimenhydrinate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
General Drowsiness may be experienced by some patients, especially with high dosage. This effect frequently is not undesirable in conditions for which the drug is used.
Information for Patients Because of the potential for drowsiness, patients taking dimenhydrinate should be cautioned against operating automobiles or dangerous machinery (see WARNINGS ).
Carcinogenesis, Mutagenesis, Impairment of Fertility Mutagenicity screening tests performed with dimenhydrinate, diphenhydramine, and 8-chlorotheophylline produced positive results in the bacterial systems and negative results in the mammalian systems. There are no human data that indicate dimenhydrinate is a carcinogen or mutagen or that it impairs fertility.
Labor and Delivery The safety of dimenhydrinate given during labor and delivery has not been established. Reports have indicated dimenhydrinate may have an oxytocic effect. Caution is advised when this effect is unwanted or in situations where it may prove detrimental.
Nursing Mothers Small amounts of dimenhydrinate are excreted in breast milk. Because of the potential for adverse reactions in nursing infants from dimenhydrinate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 ).
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API