Dramamine 50 mg Tablets

Brand Name

The medication is marketed under the brand name Dramamine, a widely recognized label in the field of motion sickness prevention and treatment.

International Nonproprietary Name (INN)

The active ingredient in this product is identified globally as dimenhydrinate, a name standardized for consistency across international pharmacological practices.

Form of Release

Dramamine is available in multiple forms, including oral tablets, chewable tablets, and liquid solution. Tablets come in strengths of 50 mg, chewable tablets match this dosage, and the liquid offers 12.5 mg per 5 mL, providing versatile options for administration.

Composition

Each tablet or chewable tablet of Dramamine contains 50 mg of dimenhydrinate as the primary active substance, while the liquid contains 12.5 mg per 5 mL. The formulation includes several inactive ingredients, such as microcrystalline cellulose, which provides structural support in tablets, and lactose monohydrate, acting as a filler. Additional excipients like magnesium stearate serve as lubricants, while the chewable form includes mannitol and aspartame for taste. The liquid solution contains propylene glycol as a solvent and sodium benzoate as a preservative, ensuring stability and palatability across all forms.

Pharmacologic Properties

Pharmacodynamics

Dramamine functions as an antihistamine with anticholinergic properties, exerting its effects by blocking histamine H1 receptors in the vestibular system and central nervous system. This action suppresses the hyperactivity of the labyrinthine apparatus and the vomiting center in the medulla, reducing nausea, vomiting, and vertigo associated with motion sickness. Its anticholinergic effects further inhibit acetylcholine-mediated signals in the vestibular-cerebellar pathways, stabilizing sensory input and alleviating dizziness.

The medication also exhibits sedative properties due to its central H1 receptor blockade, promoting drowsiness that aids in calming patients during travel. Clinical studies demonstrate its ability to prevent motion sickness symptoms in 70–80% of users when taken prophylactically, with onset within 30 minutes. It does not alter underlying vestibular pathology but provides symptomatic relief, making it a practical choice for acute motion-related discomfort.

Pharmacokinetics

Following oral administration, Dramamine is absorbed efficiently from the gastrointestinal tract, with peak plasma concentrations reached within 1 to 2 hours. Bioavailability varies, with food slightly delaying absorption but not reducing overall uptake. The drug distributes widely, crossing the blood-brain barrier due to its lipophilic nature, with plasma protein binding around 70–80%, primarily to albumin.

Metabolism occurs in the liver, where dimenhydrinate is broken down into diphenhydramine and 8-chlorotheophylline, both active metabolites contributing to its effects. The half-life ranges from 5 to 10 hours, supporting dosing every 4–6 hours as needed. Elimination is predominantly renal, with 50–60% excreted in urine as metabolites and a smaller fraction unchanged, with minor fecal clearance via bile.

Indications for Use

Dramamine is prescribed for the prevention and treatment of motion sickness in adults and children, addressing symptoms like nausea, vomiting, and dizziness triggered by travel via car, plane, or boat. It is also indicated for vertigo associated with vestibular disturbances, offering relief from spinning sensations and imbalance.

In some cases, it may be used off-label for nausea unrelated to motion, such as postoperative recovery or mild chemotherapy side effects, though efficacy varies. It suits individuals needing short-term symptom control during activities prone to inducing motion-related discomfort. These applications highlight its role as a versatile antihistamine for vestibular and nausea management.

Contraindications

Dramamine is contraindicated in patients with known hypersensitivity to dimenhydrinate, diphenhydramine, or any formulation component, such as aspartame in chewables, where reactions could range from rash to anaphylaxis. It is also prohibited in those with narrow-angle glaucoma, as its anticholinergic effects may increase intraocular pressure.

Severe respiratory conditions like asthma or chronic obstructive pulmonary disease (COPD) in acute exacerbation preclude its use due to potential respiratory depression. Patients with urinary retention, severe liver disease, or a history of seizures should avoid it, as should neonates and infants under 2 years due to heightened sensitivity. Use with monoamine oxidase inhibitors (MAOIs) is restricted due to risk of potentiation.

Method of Administration and Dosage

Administration Guidelines

The tablets or chewable tablets should be taken orally, swallowed whole or chewed with water, ideally 30–60 minutes before travel to prevent motion sickness. The liquid solution requires measuring with a provided device and can be taken with or without food. Timing prophylactically enhances efficacy, and hydration supports administration comfort.

Dosage for Adults and Children

For adults and children over 12, the typical dose of Dramamine is 50–100 mg every 4–6 hours as needed, not exceeding 400 mg daily. Children aged 6–12 receive 25–50 mg every 6–8 hours, up to 150 mg daily, while those aged 2–5 use 12.5–25 mg (liquid preferred) every 6–8 hours, up to 75 mg daily. Infants under 2 are not prescribed this therapy due to safety concerns.

Dose Adjustment in Specific Conditions

In mild to moderate renal or liver impairment, standard doses are used with caution, while severe cases may require reduction or avoidance due to metabolite accumulation. Elderly patients or those with drowsiness sensitivity may start at 25 mg per dose, adjusted by response. Short-term use limits accumulation, and dosing should align with symptom duration, not exceeding 24–48 hours without medical advice.

Side Effects

Dramamine may cause a range of side effects, though many patients experience only mild reactions with short-term use. Common issues include drowsiness, dry mouth, or blurred vision, reflecting its antihistamine and anticholinergic properties. Dizziness, fatigue, or mild headache are also reported, often subsiding post-dose.

Less frequent effects include constipation, urinary retention, or tachycardia, linked to its cholinergic blockade. Rare but serious reactions, such as paradoxical excitation (especially in children), severe sedation, or allergic responses (e.g., rash), require discontinuation and medical attention. Confusion or memory issues may occur in sensitive individuals. Limiting use duration helps manage these effects effectively.

Overdose

Symptoms of Overdose

Excessive intake of Dramamine may lead to severe drowsiness, confusion, or hallucinations, with higher doses causing seizures, respiratory depression, or coma. Anticholinergic symptoms like dry skin, dilated pupils, or flushing are possible, reflecting toxicity. Symptoms escalate with doses exceeding 1,000 mg, though thresholds vary.

First Aid Measures

In case of overdose, medical consultation is urgent, with activated charcoal considered within 1 hour to limit absorption. Treatment focuses on supportive care, such as airway management or fluids, and physostigmine may reverse severe anticholinergic effects under supervision. Monitoring vital signs and neurological status is critical until recovery, typically within 24 hours.

Drug Interactions

Effects on Other Medications

Dramamine potentiates central nervous system depressants like sedatives, opioids, or alcohol, increasing drowsiness risk, and enhances anticholinergic drugs (e.g., atropine), amplifying side effects like dry mouth or confusion. Co-use with MAOIs may prolong and intensify effects, requiring a 14-day washout. It may mask ototoxicity symptoms of drugs like aminoglycosides.

It does not significantly affect cytochrome P450 enzymes, minimizing interactions with drugs like warfarin. Patients should report all medications to their healthcare provider to avoid additive sedative or anticholinergic effects, especially in short-term use.

Compatibility with Alcohol and Food

Alcohol significantly enhances sedation and should be avoided during therapy to prevent excessive drowsiness. Food does not affect absorption significantly, allowing administration with or without meals, though a light snack may reduce nausea during use.

Special Precautions

Use During Pregnancy and Breastfeeding

Dramamine is Category B in pregnancy, with no clear fetal harm in limited data, used cautiously if benefits outweigh risks, typically for severe nausea. It passes into breast milk, potentially causing sedation in infants, so breastfeeding mothers should avoid it or pump and discard milk during short-term use, guided by medical advice.

Women of childbearing age should confirm non-pregnant status before frequent use and discuss risks with their provider during travel planning.

Impact on Driving and Operating Machinery

The medication causes drowsiness in most patients, prohibiting driving or machinery use during therapy and for several hours post-dose. Individuals should avoid such activities until sedative effects clear, typically 6–8 hours, with caution advised even after single doses.

Considerations for Elderly and Pediatric Populations

Elderly patients may experience heightened sedation or confusion, requiring lower doses (e.g., 25 mg) and monitoring for falls. Children over 2 can use age-adjusted dosing safely, while those under 2 are contraindicated due to risk of severe sedation or paradoxical excitation.