Gravol (Dimenhydrinate)

GRAVOL® Preparations

Carter Horner

Dimenhydrinate

Antiemetic – Antivertigo

Indications And Clinical Uses: Prevention or relief of motion sickness, radiation sickness, postoperative vomiting, and drug induced nausea and vomiting; it has also been used for the symptomatic relief of nausea and vertigo due to Meniere’s disease and other labyrinthine disturbances.

Contra-Indications: Glaucoma, chronic lung disease, difficulty in urination due to prostatic hypertrophy.

Manufacturers’ Warnings In Clinical States: As dimenhydrinate has a CNS depressant effect, the concomitant use of alcohol should be avoided.

If Gravol I.M. is required for i.v. use, it must be diluted at least 1:10 with a compatible physiological solution such as sterile saline or 5% dextrose in water, to prevent propylene glycol-associated serious adverse reactions, and should be injected slowly over 2 to 3 min.

Occupational Hazards: Patients receiving dimenhydrinate should be cautioned against operating automobiles or dangerous machinery because of drowsiness associated with the drug. If drowsiness is excessive, dosage should be reduced.

It should be borne in mind that antiemetics should be used with caution since they may mask the presence of underlying organic abnormalities or the toxic effects of other drugs.

Patients in whom anticholinergics may aggravate other clinical conditions, should use dimenhydrinate with caution, and preferably on a physician’s advice. Patients should not take dimenhydrinate with other antihistamines, tranquilizers or any other sedative drugs without first consulting their physician.

Pregnancy and Lactation: The use of dimenhydrinate by women who are pregnant or may become pregnant, or nursing mothers, require that potential benefits be weighed against the potential risks.

Adverse Reactions: Drowsiness may be experienced by some patients, especially at high dosages. Dizziness may also occur. Symptoms of dry mouth, lassitude, excitement (especially in children) and nausea have been reported.

Symptoms And Treatment Of Overdose: Children are susceptible to the convulsant action of antihistamines. Cases of convulsions and eventually coma have been reported in children 1.5 to 3 years (especially in the presence of dehydration) having received large doses of 150 to 800 mg diphenhydramine HCl (equivalent to 260 to 1 400 mg dimenhydrinate). There have been reports of hallucinations after the ingestion of 500 and 700 mg dimenhydrinate.Symptoms: Drowsiness, ataxia, disorientation, nystagmus, convulsions, stupor, coma and respiratory depression.

Treatment: No specific antidote. Gastric lavage. If coma and respiratory depression are present, use resuscitative measures, not stimulants. Maintain blood pressure with dopamine or levarterenol bitartrate. It has been reported that anticholinergic induced delirium, confusion, hallucinations, agitation, ataxia, dysarthria and somnolence are reversed by i.v. or s.c. administration of 1 to 2 mg physostigmine salicylate.

Dosage And Administration: Motion Sickness: Initial dose should be taken at least 1/2 hour and preferably 1 to 2 hours before departure.

Adults: For the treatment of motion sickness, nausea, vomiting, dizziness and vertigo: 50 to 100 mg every 4 hours if necessary to a maximum of 400 mg in 24 hours. For extended relief: 1 to 2 Gravol 75 mg long acting capsules every 8 hours to a maximum of 5 capsules in 24 hours. Rectal: 50 to 100 mg suppository every 6 to 8 hours as necessary. (For ease and comfort smooth any edges on suppository prior to use.)

Radiation Sickness: 50 to 100 mg administered rectally or parenterally, 30 to 60 minutes before treatment. This dose is repeated as necessary to a maximum of 400 mg in 24 hours.

To control postoperative nausea and vomiting: 50 to 100 mg may be administered orally or 50 mg i.m. as a preoperative dose to be followed postoperatively by similar doses as needed to a maximum of 400 mg in 24 hours.

Children: Under 1 year: Not recommended.

Children: Under 2 years: As directed by a physician.

2 to 6 years: Oral: 15 to 25 mg every 6 to 8 hours as necessary to a maximum of 75 mg in 24 hours. Rectal: 12.5 to 25 mg not to be repeated except on the advice of a physician.

6 to 8 years: Oral: 25 to 50 mg every 6 to 8 hours as necessary to a maximum of 150 mg in 24 hours. Rectal: 12.5 to 25 mg every 8 to 12 hours as necessary.

8 to 12 years: Oral: 25 to 50 mg every 6 to 8 hours as necessary to a maximum of 150 mg in 24 hours. Rectal: 25 to 50 mg every 8 to 12 hours as necessary.

12 years and over: Oral: 50 mg every 4 to 6 hours as necessary to a maximum of 300 mg in 24 hours. Rectal: 50 mg every 8 to 12 hours as necessary.

Availability And Storage: I.V. Ampuls: Each single dose ampul of clear solution contains: dimenhydrinate 50 mg and must be administered by slow i.v. injection only. Nonmedicinal ingredients: alcohol 17%. Tartrazine-free. Ampuls of 5 mL, boxes of 10. Store at controlled room temperature (15 to 30°C). Protect from freezing.

I.M. Injection: Each mL contains: dimenhydrinate 50 mg. This dosage form is for i.m use only, unless diluted at least 1:10 with a compatible physiological solution, i.e., sterile saline or 5% dextrose in water. Nonmedicinal ingredients: methylparaben (multidose vials only), propylene glycol and propylparaben (multidose vials only). Tartrazine-free. Multidose vials of 5 mL, boxes of 3 and 25. Unit dose ampuls of 1 mL (preservative-free), boxes of 10. Store at controlled room temperature (15 to 30°C). Protect from freezing.

L/A Capsules: Each No. 1 hard gelatin capsule with blue top and clear bottom holding a white powder with hard, pink coated granules distributed throughout, contains: 25 mg of dimenhydrinate for immediate release and 50 mg of dimenhydrinate for sustained release. Nonmedicinal ingredients: cellulose, FD&C Blue No. 1, FD&C Red No. 2 and No. 3, gelatin, lactose, light mineral oil, magnesium stearate, povidone, shelac, silicon dioxide, sodium lauryl sulfate. starch (corn and wheat) (contains gluten) and talc. Energy: 5 kJ (1.2 kcal)/capsule. Tartrazine-free. Push through packages of 10 and 30; bottles of 100 and 500.

Liquid: Each 5 mL of yellow, transparent, viscous liquid with a bittersweet mixed fruit flavor, contains: dimenhydrinate 15 mg. Nonmedicinal ingredients: citric acid, D&C Yellow No. 10, FD&C Yellow No. 6, flavor, propylene glycol, sodium benzoate, sorbitol and sucrose. Energy: 61.5 kJ (14.7 kcal)/5 mL. Sodium:

Suppositories: Each white, opaque suppository contains: dimenhydrinate 25 mg children or 50 mg junior both with rounded nose or 100 mg (adult) with a pointed nose. Nonmedicinal ingredients: polyethylene glycol, silicon dioxide and titanium dioxide. Gluten- and tartrazine-free. Boxes of 10 and 100. Individually sealed in foil. Store in a cool place.

Filmkote Tablets: 15 mg: Each round, biconvex, yellow lime tablet, intagliated GRAVOL on one side, contains: dimenhydrinate 15 mg. Nonmedicinal ingredients: alumina, cellulose, D&C Yellow No. 10, FD&C Blue No. 2, glycerin, lactose, magnesium stearate, propylene glycol, silicon dioxide, starch (corn), talc and titanium dioxide. Energy: 1 kJ (0.2 kcal). Gluten- and tartrazine-free. Push through packages of 10.

25 mg (Junior Strength): Each round, biconvex, pale yellow tablet, intagliated GRAVOL on one side, contains: dimenhydrinate 25 mg. Nonmedicinal ingredients: alumina, cellulose, D&C Yellow No. 10, FD&C Yellow No. 6 and Blue No. 2, lactose, magnesium stearate, polyethylene glycol, povidone, silicon dioxide, starch (corn), talc and tianium dioxide. Energy: 1.3 kJ (0.3 kcal). Gluten- and tartrazine-free. Push through packages of 10.

50 mg: Each round, biconvex, peach coral tablet, intagliated GRAVOL on one side and quadrisected on the other, contains: dimenhydrinate 50 mg. Nonmedicinal ingredients: alumina, cellulose, FD&C Yellow No. 6, lactose, magnesium stearate, polyethylene glycol, silicon dioxide, starch (corn), talc and titanium dioxide. Energy: 1.3 kJ (0.3 kcal)/tablet. Gluten- and tartrazine-free. Push through packages of 10 and 30; bottles of 100 and 1 000, unit dose cartons of 5´20 and unit dose tins of 1 000.

Chewable Tablets for Children: Each round, flat, light purple, cherry-flavored tablet with bevelled edge intagliated GRAVOL 15 mg on one side, plain on the other side, contains: dimenhydrinate 15 mg. Nonmedicinal ingredients: alumina, aspartame, cellulose, citric acid, FD&C Red No. 40, flavors, magnesium stearate, methacrylic acid copolymer, monoglycerides, polyethylene glycol, sorbitol and starch (corn). Energy: 5.8 kJ (1.4 kcal). Gluten- and tartrazine-free. Push through packages of 12.

Chewable Tablets for Adults: Each round, flat, light pink, orange-flavored tablet with bevelled edge, intagliated GRAVOL 50 on one side, bisected on the other side, contains: dimenhydrinate 50 mg. Nonmedicinal ingredients: alumina, aspartame, cellulose, citric acid, FD&C Yellow No. 6, flavors, magnesium stearate, methacrylic acid copolymer, monoglycerides, polyethylene glycol, sorbitol and starch (corn). Energy: 10.9 kJ (2.6 kcal). Gluten- and tartrazine-free. Push through packages of 8. (Shown in Product Recognition Section)

GRAVOL® Preparations Carter Horner Dimenhydrinate Antiemetic – Antivertigo

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Meniere’s Disease

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