DRUGS & SUPPLEMENTS
INDICATIONS AND USAGE
Dramamine Injection, USP is indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness.
Neonates and patients with a history of hypersensitivity to Dramamine or its components (diphenhydramine or 8-chlorotheophylline) should not be treated with Dramamine.
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.
Caution should be used when Dramamine is given in conjunction with certain antibiotics that may cause ototoxicity, since Dramamine 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.
Dramamine should be used with caution in patients having conditions which might be aggravated by anticholinergic therapy.
The preparation should not be injected intra-arterially.
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 ).
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 Dramamine should be cautioned against operating automobiles or dangerous machinery.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Mutagenicity screening tests performed with Dramamine, 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 Dramamine is a carcinogen or mutagen or that it impairs fertility.
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, and have revealed no evidence of impaired fertility or harm to the fetus due to Dramamine. There are no adequate and well-controlled studies in pregnant women. However, clinical studies in pregnant women have not indicated that Dramamine 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, Dramamine should be used during pregnancy only if clearly needed.
Labor and Delivery
The safety of Dramamine given during labor and delivery has not been established. Reports have indicated Dramamine may have an oxytocic effect. Caution is advised when this effect is unwanted or in situations where it may prove detrimental.
Small amounts of Dramamine are excreted in breast milk. Because of the potential for adverse reactions in nursing infants from Dramamine, 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.
The most frequent adverse reaction to Dramamine 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.
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 LD50 in mice and rats is 203 mg/kg and 1320 mg/kg, respectively. The intraperitoneal LD50 in mice is 149 mg/kg.
DOSAGE AND ADMINISTRATION
Dramamine in the injectable form is indicated when the oral form is impractical.
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 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.
For intramuscular administration, 1.25 mg/kg of body weight or 37.5 mg/m2 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.
Dramamine Injection, USP, 50 mg/mL is available in multiple dose amber vials, as follows:
Protect from light.
Store at 20° to 25°C (68° to 77°F).
Vial stoppers do not contain natural rubber latex.
Revised: April 2008
logo PACKAGE LABEL - PRINCIPAL DISPLAY - Dramamine 1 mL Vial Label
Dramamine INJECTION, USP
For IM Use
For IV Use: See package insert.
1 mL Multiple Dose Vial
PACKAGE LABEL - PRINCIPAL DISPLAY - Dramamine 1 mL Tray Label
Dramamine INJECTION, USP
For IM Use
*For IV Use
1 mL Multiple Dose Vial
Dramamine pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Dramamine available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Dramamine destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Dramamine Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Dramamine pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Dramamine?
Depending on the reaction of the Dramamine after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dramamine not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Dramamine addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Dramamine, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Dramamine consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reported usefulNo survey data has been collected yet
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Visitor reported price estimatesNo survey data has been collected yet
Visitor reported frequency of useNo survey data has been collected yet
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One visitor reported age
The information was verified by Dr. Arunabha Ray, MD Pharmacology