Al-Tinez Pharmaceuticals Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Tel: 01-4826452; 0802-307-7320, 0803-305-7978

Brand Name



Sa Okim Pharmaceuticals Joint Company, Quang Minh Industrial Zone - Me Linh - Ha Noi - Viet Nam.

Therapeutic Class

Antihistamines, Systemic

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Tablet (NRN: A4-4417): Loratadine 10 mg Excipients: Lactose, amidon, polyvinyl pyrrolidone, magnesium stearate, talcum q.s 1 tablet.

Pack size: Box of 1 blister x 10 tablets, box of 10 blisters x 10 tablets.

 lorax tab

Syrup(NRN:    ): Each 5 mL contains: Loratadine USP 5 mg. Excipients Q.S.Colour: Tartrazine.

Pack size: 100 mL SYRUP pack in Bottles.



Loratadine is a white to off-white powder not soluble in water, but very soluble in acetone, alcohol, and chlorofom. Molecular weight of 382.89(C22H23CIN2O2)

Chemical name is ethyl4-(8-chloro-5, 6-dihydro-11 H-benzo [5, 6 cyclohepta[1,2-b]pyridin-11-ylidene)-1 -piperidinecarboxylate

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

Mode of action:

Competitively antagonizes histamine at the H1-receptor site.


Absorption: Rapidly absorbed following oral administration. Tmax is 1.3 h for loratadine and 2.5 h for its metabolite. Food increases bioavailability (AUC) by approximately 40%; however, Tmax is delayed  by 1 h. Steady state is reached by approximately the fifth dosing day.

Distribution: 97% protein bound.

Metabolism: Metabolite is descarboethoxyloratadine. Metabolized by CYP450 3A4 and P450 2D6. Undergoes extensive first-pass metabolism.

Elimination: Approximately 80% equally distributed between urine and feces in the form of metabolic products within 10 days. The t½ for loratadine is 8.4 h (3 to 20 h). The t½ for descarboethoxyloratadine is 28 h (8.8 to 92 h).


Loratadine is indicated for the relief of nasal and non nasal symptoms of seasonal allergic rhinitis and for the treatment of chronic idiopathic urticaria in patients 2 year of age or older.

In adults and children 6 years of age and over with liver failure or renal insufficiency (GFR

In children 2 to 5 years of age with liver failure or renal insufficiency, the starting dose should be 5 mg (one teaspoonful) every other day.

Lorax contains loratadine which is a non-sedating antihistamine.

Lorax works by inhibiting the action of histamine, a chemical of natural origin responsible for the symptoms of allergy.

Lorax does not cause drowsiness, unlike other available antihistamines.

Lorax is used to relieve symptoms associated with allergy:

  • Seasonal and perennial allergic rhinitis, such as sneezing, rhinorrhea, and nasal itching.
  • Allergic conjunctivitis, ocular itching and burning.
  • Chronic urticaria and dermatitis, allergic dermatological conditions.


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


Patients with liver impairment or renal insufficiency (GFR

Loratadine should be used during pregnancy only if clearly needed.

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

The safety of loratadine syrup or tablet at a daily dose of 10 mg 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.

Lorax should be taken with medical advice if you have severe liver impairment. Your doctor may decrease your initial dose. An initial dose of 5 mg per administration daily or 10 mg every other day is recommended.

The safety and efficacy of loratadine in children younger than 2 years of age has not been established.


When administered concomitantly with alcohol, loratadine has no potential effects as measured by psychomotor performance studies.

Increase in plasma concentrations of loratadine have been reported after concomitant use with ketoconazole, erythromycin or cimetidine in controlled clinical trials, but without clinically significant changes (including electrocardiogram).

Other drugs known to inhibit hepatic metabolism should be coadministered with caution until definitive interaction studies can be completed.

Loratadine should be discontinued approximately 48 hours prior to skin testing procedures since these drugs may prevent or diminish otherwise positive reactions to dermal reactivity indicators.

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

Adverse Effects

Discontinue the treatment and seek medical treatment in emergency if you experience:

  • Allergic reactions to antihistamines characterized by difficulty in breathing, constriction of the throat, swelling of the face, mouth and tongue.
  • Palpitations or irregular heart beat
  • Seizures and convulsions

You may also experience mild side effects such as: drowsiness, headaches or dizziness, nervousness, nausea, stomach disorders such as diarrhea, dry mouth, dry skin and irritation, discoloration of urine.

Report any side effects to physician or pharmacist during period of treatment.

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, paresthesia, tremor, vertigo.

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

Musculoskeletal System: Arthralgia, myalgia.

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

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

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

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

Dosage & Administration

Lorax is used by oral route.

Adults and children 12 years of age and over: 1 tablet per administration daily.

Children from 2 to 12 years of age: Over 30 kg: 1 tablet per administration daily

Below 30 kg: ½ tablet per administration daily.


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

Children 2 to 5 years of age: Recommended dose of LORAX Syrup is 5 mg (1 teaspoonful) once daily.


In adults, somnolence, tachycardia, and headache have been reported.

Extrapyramidal signs and palpitations have been reported in children.

Storage/Handling Recommendations

Store in a cool dry place below 28ºC. Protect from light.

Keep away from the reach of children.

Review Date

2017-11-24 12:19:58