Drug Interaction:
Antihistamines Include:
First Generation ( Non-selective ) Ethanolamine- Carbinoxamine. Clemastine, Diphenhydramine. Ethylenediamines- Pyrilamine, Triplennamine Akylamines- Brompheneramine, Chlorpheniramine, Dexchlor pheniramine,Pheniramine,Triprolidine
Phenothiazines
Methidilazine, Promethizine, trimeprazine Piperidines- Azatadine, Cyproheptadine, Phenindamine Miscellaneous- Astemazole, Loratadine, Terfenadine Second Generation ( Peripherally selective ) Phthalazinone - Azelastine Piperazine - Cetrizine Refer - Chlorpheniramine maleate
Indication:
Allergic conditions
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
Loratadine Long Acting Histamine June 1992
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Loratidine 10mg + 17-09-1999
Pseudoephedrine sulphate
in ER form 180mg film coated tablet
Allergic and seasonal rhinitis only
2.Loratidine 5mg + 21-08-1996
Pseudoephedrine 120mg ER tablets
For relief of symptoms of seasonal allergic rhinitis
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Loratidine Respiratory Schering-Plough 19-06-2002
Metabolite
Adverse Reaction:
Most common - CNS Depression, effects varying from slight drowsiness to deep sleep, including lassitude , dizziness, and incordination These sedative effects when they occur may diminsh after a few days of treatment
Others- headache, psychomotor impairment, antimuscarinic effect such as dry mouth, thickened respiratory tract secetions, blurred vision, urinary difficulty, or retention, constipation and increased gastric reflux giddiness, dizzinees, dry mouth, headache, sedation, nausea and pruritis.
Contra-Indications:
Hypersens, neonates. Special precautions: Lactation, severe hepatic damage.
Dosages/ Overdosage Etc:
Indications:
Allergic conditions
Dosage:
Adults and children above 12 years- 10mg once daily on an empty stomach.
Children below 12 years- safety and efficay not established.
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
Patient Information:
Antihistamines Include: First Generation ( Non-selective )
Ethanolamine- Carbinoxamine. Clemastine, Diphenhydramine. Ethylenediamines- Pyrilamine, Triplennamine Akylamines- Brompheneramine, Chlorpheniramine, Dexchlor pheniramine,Pheniramine,Triprolidine
Phenothiazines- Methidilazine, Promethizine, trimeprazine Piperidines- Azatadine, Cyproheptadine, Phenindamine Miscellaneous- Astemazole, Loratadine, Terfenadine Second Generation ( Peripherally selective ) Phthalazinone - Azelastine Piperazine - Cetrizine Refer - Chlorpheniramine maleate
1. Inform patients of a history of glaucoma, peptic ulcer, urinary retention, or pregnancy before starting antihistamine therapy
2. May cause nervousness, insomnia, and dry mouth
3. May cause drowsiness, or dizziness(except astemazole,loratadine, and tefenadine)
4. Patients should observe caution while driving or performing other tasks requiring alertness, coordination or physical dexterity.
5. Avoid alcohol and other CNS depressants (eg,. sedatives, hypnotics, tranquilizers)
6. May cause GI upset, take with food. Take Astemazole on an empty stomach, at least 2 hours after or 1 hour before a meal.
Take Lorantidine on an empty stomach.
7. Avoid prolonged exposure to sunlight, may cause photosentivity.
8. Do not crush or chew sustained releae preparations
9.Astemazole/ Terfenadine: Patients should not take these agents if they have hepatic dysfunction or if they are also receiving ketoconazole, itraconazole or erythromycin
10. Phenothiazines- Patients should report any involuntary muscle movements or unusual sensitivity to sunlight.
Pharmacology/ Pharmacokinetics:
Refer antihistamines
Interaction with Food:
Administration on empty stomach recommended.
Pregnancy and lactation:
Refer antihistamines
Manufacturer Details