Reniveze may be available in the countries listed below.
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Reniveze in the following countries:
International Drug Name Search
Vimultisa may be available in the countries listed below.
Diclofenac potassium salt (a derivative of Diclofenac) is reported as an ingredient of Vimultisa in the following countries:
International Drug Name Search
Coryol may be available in the countries listed below.
Carvedilol is reported as an ingredient of Coryol in the following countries:
International Drug Name Search
In some countries, this medicine may only be approved for veterinary use.
In the US, Fulvicin U/F (griseofulvin systemic) is a member of the drug class miscellaneous antifungals and is used to treat Dermatophytosis, Onychomycosis - Fingernail, Onychomycosis - Toenail, Tinea Barbae, Tinea Capitis, Tinea Corporis, Tinea Cruris and Tinea Pedis.
US matches:
Griseofulvin is reported as an ingredient of Fulvicin U/F in the following countries:
International Drug Name Search
Montelukast La Santé may be available in the countries listed below.
Montelukast sodium salt (a derivative of Montelukast) is reported as an ingredient of Montelukast La Santé in the following countries:
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Brupen may be available in the countries listed below.
Ampicillin trihydrate (a derivative of Ampicillin) is reported as an ingredient of Brupen in the following countries:
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Dimenhydrinate, an anti-nauseant/antiemetic, is the 8-chlorotheophylline salt of diphenhydramine. It contains not less than 53% and not more than 55.5% of diphenhydramine, and not less than 44% and not more than 47% of 8-chlorotheophylline, calculated on the dried basis. Chemically, it is 8-chlorotheophylline compound with 2(diphenylmethoxy)-N,N-dimethylethylamine (1:1), and the structural formula is:
C17H21NO•C7H7ClN4O2 M.W. 469.96
Dimenhydrinate Injection, USP contains a sterile solution of Dimenhydrinate 50 mg/mL; Propylene Glycol 50%; Benzyl Alcohol 5% as preservative; and Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid may have been used to adjust pH.
While the precise mode of action of Dimenhydrinate is not known, it has a depressant action on hyperstimulated labyrinthine function.
Dimenhydrinate 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 Dimenhydrinate or its components (diphenhydramine or 8-chlorotheophylline) should not be treated with Dimenhydrinate.
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 Dimenhydrinate is given in conjunction with certain antibiotics that may cause ototoxicity, since Dimenhydrinate 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.
Dimenhydrinate should be used with caution in patients having conditions which might be aggravated by anticholinergic therapy (i.e., prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, bladder neck obstruction, narrow-angle glaucoma, bronchial asthma, or cardiac arrhythmias).
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 Dimenhydrinate should be cautioned against operating automobiles or dangerous machinery (see WARNINGS).
Mutagenicity screening tests performed with Dimenhydrinate, 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 Dimenhydrinate 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 (on a mg/kg basis), and have revealed no evidence of impaired fertility or harm to the fetus due to Dimenhydrinate. There are no adequate and well-controlled studies in pregnant women. However, clinical studies in pregnant women have not indicated that Dimenhydrinate 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, Dimenhydrinate should be used during pregnancy only if clearly needed.
The safety of Dimenhydrinate given during labor and delivery has not been established. Reports have indicated Dimenhydrinate may have an oxytocic effect. Caution is advised when this effect is unwanted or in situations where it may prove detrimental.
Small amounts of Dimenhydrinate are excreted in breast milk. Because of the potential for adverse reactions in nursing infants from Dimenhydrinate, 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 Dimenhydrinate 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.
Dimenhydrinate 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 (50 mg) 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.
Dimenhydrinate Injection, USP, 50 mg/mL is available in multiple dose amber vials, as follows:
Product No. | NDC No. | Strength | Vial Size |
361601 | 63323-366-01 | 50 mg/mL | 1 mL in 2 mL vial, in packages of 25. |
361610 | 63323-366-10 | 50 mg/mL | 10 mL in a 10 mL vial, packaged individually. |
Protect from light.
Store at 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].
Vial stoppers do not contain natural rubber latex.
45981B
Revised: April 2008
NDC 63323-366-01
361601
Dimenhydrinate 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 - Dimenhydrinate 1 mL Tray Label
NDC 63323-366-01
361601
Dimenhydrinate INJECTION, USP
50 mg/mL
For IM Use
*For IV Use
Rx only
1 mL Multiple Dose Vial
| Dimenhydrinate Dimenhydrinate injection, solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA040519 | 11/29/2004 | |
| Labeler - APP Pharmaceuticals, LLC (608775388) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| APP Pharmaceuticals, LLC | 840771732 | MANUFACTURE | |
Tamsul may be available in the countries listed below.
Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Tamsul in the following countries:
International Drug Name Search
Generic Name: desloratadine (DES lor A ta deen)
Brand names: Clarinex, Clarinex Reditabs, Neoclarityn, Aerius
Desloratadine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Desloratadine is used to treat the symptoms of allergies, such as sneezing, watery eyes, and runny nose. It is also used to treat skin hives and itching in people with chronic skin reactions.
Desloratadine may also be used for purposes not listed in this medication guide.
Before taking desloratadine, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.
Desloratadine disintegrating tablets (Clarinex RediTabs) may contain phenylalanine. Talk to your doctor before using this form of desloratadine if you have phenylketonuria (PKU).
To make sure you can safely take desloratadine, tell your doctor if you have any of these other conditions:
Desloratadine disintegrating tablets (Clarinex RediTabs) may contain phenylalanine. Talk to your doctor before using this form of desloratadine if you have phenylketonuria (PKU).
Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.
Desloratadine is usually taken once per day. Follow your doctor's instructions.
Measure the liquid form of desloratadine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
To take desloratadine orally disintegrating tablet (Clarinex RediTabs):
Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.
Using dry hands, remove the tablet and place it on your tongue. It will begin to dissolve right away.
Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.
Swallow several times as the tablet dissolves. If desired, you may drink water to help swallow the dissolved tablet.
Call your doctor if your symptoms do not improve.
See also: Desloratadine dosage (in more detail)
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include fast heart rate.
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
fast, pounding, or uneven heartbeat;
fever, flu symptoms;
seizure (convulsions); or
jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
dry mouth, sore throat, cough;
muscle pain;
drowsiness, tired feeling;
nausea, diarrhea; or
headache.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Allergic Rhinitis:
Initial dose: 5 mg orally once a day
Maintenance dose: 5 mg orally once a day
Usual Adult Dose for Urticaria:
Initial dose: 5 mg orally once a day
Maintenance dose: 5 mg orally once a day
Usual Geriatric Dose for Allergic Rhinitis:
Initial dose: 5 mg orally once a day.
Maintenance dose: 5 mg orally once a day.
Usual Geriatric Dose for Urticaria:
Initial dose: 5 mg orally once a day.
Maintenance dose: 5 mg orally once a day.
Usual Pediatric Dose for Allergic Rhinitis:
>=6m >=1y >=6y >=12 years of age: 5 mg orally once a day
Usual Pediatric Dose for Urticaria:
>=6m >=1y >=6y >=12 years of age: 5 mg orally once a day
There may be other drugs that can interact with desloratadine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: desloratadine side effects (in more detail)
Lidocaina Lusa may be available in the countries listed below.
Lidocaine is reported as an ingredient of Lidocaina Lusa in the following countries:
International Drug Name Search
Cero may be available in the countries listed below.
Cefaclor is reported as an ingredient of Cero in the following countries:
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Cero in the following countries:
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Relexid may be available in the countries listed below.
Pivmecillinam is reported as an ingredient of Relexid in the following countries:
International Drug Name Search
