DRUGS & SUPPLEMENTS
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Dimenate 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 Dimenate or its components (diphenhydramine or 8-chlorotheophylline) should not be treated with Dimenate.
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 Dimenate is given in conjunction with certain antibiotics that may cause ototoxicity, since Dimenate 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.
Dimenate 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.
Because of the potential for drowsiness, patients taking Dimenate should be cautioned against operating automobiles or dangerous machinery.
Mutagenicity screening tests performed with Dimenate, 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 Dimenate 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 Dimenate. There are no adequate and well-controlled studies in pregnant women. However, clinical studies in pregnant women have not indicated that Dimenate 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, Dimenate should be used during pregnancy only if clearly needed.
The safety of Dimenate given during labor and delivery has not been established. Reports have indicated Dimenate may have an oxytocic effect. Caution is advised when this effect is unwanted or in situations where it may prove detrimental.
Small amounts of Dimenate are excreted in breast milk. Because of the potential for adverse reactions in nursing infants from Dimenate, 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 Dimenate 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.
Dimenate 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.
Dimenate Injection, USP, 50 mg/mL is available in multiple dose amber vials, as follows:
1 mL in 2 mL vial, in packages of 25.
10 mL in a 10 mL vial, packaged individually.
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 - Dimenate 1 mL Vial Label
Dimenate INJECTION, USP
For IM Use
For IV Use: See package insert.
1 mL Multiple Dose Vial
PACKAGE LABEL - PRINCIPAL DISPLAY - Dimenate 1 mL Tray Label
Dimenate INJECTION, USP
For IM Use
*For IV Use
1 mL Multiple Dose Vial
Depending on the reaction of the Dimenate after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Dimenate 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 Dimenate 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.
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The information was verified by Dr. Rachana Salvi, MD Pharmacology