Atadyn Loratadine Solution and Tablet

Atadyn® Loratadine Oral Solution USP 5mg /5 ml and Tablets USP 10mg

Description, Composition, Node of action, Indications, Dosage and administration, Side effects, Drug interactions, Precautions, Pregnancy nursing mother and pediatric use, Overdose, Contraindications, Storage, Presentation and Manufacturer of Atadyn Suspension,Tablet Medicine for Catarrh.

 

DESCRIPTION

Loratadine is a white to off-white powder not soluble in water, but very soluble in acetone, alcohol, and chloroform. Molecular weight of 382.89(C22H23C1N2O2).
Chemical name is ethyl4-(8-chloro-5,6-dihydro-11H-benzo(5,6)cyclohepta[ I ,2-b]pyridin11-ylidene)-1- piperidinecarboxylate.

 

COMPOSITION

Each uncoated tablet contains:

Loratadine USP 10mg

Excipient QS.

 

Each 5ml contains:

Loratadine USP 5mg.

 

Excipients QS

Colour: Tartrazine

 

MODE OF ACTION

Loratadine is a long-acting tricyctic ANTIHISTAMINE with selective peripheral histamine H1-receptor antagonistic activity.

 

INDICATIONS

Loratadine is indicated for the relief of nasal and non nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic diopathic urticaria in patients 2 years of age or older. In adults and children 6 years of age and over with liver failure or renal insufficiency (GFR <30 mL/min), the starting dose should be 10mg (one tablet or two teaspoonfuls) every other day. In children 2 to 5 years of age with liver failure or renal insufficiency, the starting dose should be 5mg (one teaspoonful) every other day.

 

DOSAGE AND ADMINISTRATION

Adults and children 6 years of age and over: Recommended dose of ATADYN 10mg tablet or 2 teaspoonfuls (10mg) of syrup once daily.

Children 2 to5years of age: Recommended dose of ATADYN Syrup is 5mg (1 teaspoonful) once daily.

 

SIDE EFFECTS

Angioneurotic edema, asthenia, back pain, blurred vision, chest pain, earache, eye pain, fever, leg cramps, malaise, rigors, tinnitus, viral infection, weight gain, abnormal hepatic function, including jaundice, hepatitis, and hepatic necrosis; alopecia; anaphylaxis; breast enlargement; erythema multiforme; peripheral edema; and seizures.

ANS: Altered lacrimation, altered salivation, flushing, hypoesthesia, impotence, increased sweating, thirst.

CVS: Hypertension, hypotension, palpitations, supraventricular tachyarrhythmias, syncope, tachycardia.

CNS & PNS: Blepharospasm, dizziness, dysphonia, hypertonia, migraine, parenthesia, tremor, vertigo.

Gastrointestinal System: Altered taste, anorexia, constipation, diarrhea, dyspepsia, flatulence, gastritis, hiccup, increased appetite, nausea, stomatitis, toothache, vomiting.

Musculoskeletal Sysfem: Arthralgia, myalgia.

Psychiatric: Agitation, amnesia, anxiety, confusion, decreased libido, depression, impaired concentration, insomnia, irritability paroniria.

Reproductive System: Breast pain, dysmenorrhea, menorrhagia, vagintis.

Skin and Appendages: Dermatitis, dry hair, dry skin, photosensitivity reaction, pruritus, purpura, rash, urticaria.

Urinary System: Altered micturition, urinary discoloration, urinary incontinence, urinary retention.

 

DRUG INTERACTIONS

No effects on plasma concentrations of cimetidine or ketoconazole were observed. Plasma concentrations (AUC 0-24 hrs) of erythromycin decreased 15% with coadministration of loratadine relative to that observed with erythromycin alone.

 

PRECAUTIONS

Patients with liver impairment or renal insufficiency (GFR <30 ml/min) should be given a lower initial dose (10mg every other day).

 

PREGNANCY

Loratadine should be used during pregnancy only if clearly needed.

 

NURSING MOTHER

Caution should be exercised when loratadine is administered to a nursing woman.

 

PEDIATRIC

The safety of loratadine syrup or tablet at a daily dose of 10mg has been demonstrated in pediatric patients 6 to 12 years of age in placebo-controlled. The effectiveness of loratadine for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria.

 

OVERDOSE

In adults, somnolence, tachycardia, and headache have been reported. Extrapyramidal signs and palpitations have been reported in children.

 

CONTRAINDICATIONS

Loratadine is contraindicated in patients who are hypersensitive to this medication or to any of its ingredients.

 

STORAGE

Store in a cool, dry and dark place.

 

PRESENTATION

10 TABLETS pack in blister pack.

100ml SYRUP pack in Bottles.

 

Manufactured in India by

STALLION LABORATORIES PVT. LTD.

C-1B, 305/2 & 3, G.I.D.C. Kerala (Bavia),

Dist.: Ahmedabad-382 220. Gujarat.

Advertisements