Novomin

Novomin uses

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• Novomin reviews

INDICATIONS AND USAGE

Novomin Injection, USP is indicated for the prevention and treatment of nausea, vomiting, or vertigo of motion sickness.

CONTRAINDICATIONS

Neonates and patients with a history of hypersensitivity to Novomin or its components (diphenhydramine or 8-chlorotheophylline) should not be treated with Novomin.

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.

WARNINGS

Caution should be used when Novomin is given in conjunction with certain antibiotics that may cause ototoxicity, since Novomin 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.

Novomin should be used with caution in patients having conditions which might be aggravated by anticholinergic therapy.

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 ).

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 Novomin should be cautioned against operating automobiles or dangerous machinery.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity screening tests performed with Novomin, 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 Novomin 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, and have revealed no evidence of impaired fertility or harm to the fetus due to Novomin. There are no adequate and well-controlled studies in pregnant women. However, clinical studies in pregnant women have not indicated that Novomin 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, Novomin should be used during pregnancy only if clearly needed.

Labor and Delivery

The safety of Novomin given during labor and delivery has not been established. Reports have indicated Novomin 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 Novomin are excreted in breast milk. Because of the potential for adverse reactions in nursing infants from Novomin, 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.

ADVERSE REACTIONS

The most frequent adverse reaction to Novomin 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.

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 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

Novomin 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 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/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.

HOW SUPPLIED

Novomin 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.

45981B

Revised: April 2008

logo PACKAGE LABEL - PRINCIPAL DISPLAY - Novomin 1 mL Vial Label

NDC 63323-366-01

361601

Novomin 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 - Novomin 1 mL Tray Label

NDC 63323-366-01

361601

Novomin INJECTION, USP

50 mg/mL

For IM Use

*For IV Use

Rx only

1 mL Multiple Dose Vial

361601vial 361601-tray

Novomin pharmaceutical active ingredients containing related brand and generic drugs:

• Dimenhydrinate

Novomin available forms, composition, doses:

• Syrup; Oral; Dimenhydrinate 15 mg / 5 ml
• Tablets; Oral; Dimenhydrinate 50 mg

Novomin destination | category:

• Human:
• Antiemetics
• Antivertigo drugs

Novomin Anatomical Therapeutic Chemical codes:

• A04AD - Other antiemetics

Novomin pharmaceutical companies:

• Apex Pharma Marketing
• Four Star
• Grafton Pharmasia
• Tack Fung Medical Supplies
• Xepa-Soul Pattinson

References

1. Dailymed."DIMENHYDRINATE INJECTION, SOLUTION [APP PHARMACEUTICALS, LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Depending on the reaction of the Novomin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Novomin 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.

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