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DESLERG

MECHANISM OF ACTION:

Desloratadine is a non-sedating, long-acting histamine antagonist with selective peripheral H1- receptor antagonist activity. PHARMACOKINETICS:
Absorption:
Desloratadine plasma concentrations can be detected within 30 minutes of administration. Desloratadine is well absorbed with maximum concentration achieved after approximately 3 hours; the terminal phase half-life is approximately 27 hours. The degree of accumulation of desloratadine was consistent with its half-life (approximately 27 hours) and a once daily dosing frequency. The bioavailability of desloratadine was dose proportional over the range of 5 mg to 20 mg.

Distribution:
Desloratadine is moderately bound (83% – 87 %) to plasma proteins. There is no evidence of clinically relevant medicine accumulation following once daily dosing of desloratadine (5 mg to 20 mg) for 14 days.

Biotransformation:
The enzyme responsible for the metabolism of desloratadine has not been identified yet, and therefore, some interactions with other medicinal products cannot be fully excluded. Desloratadine does not inhibit CYP3A4 in vivo, and in vitro studies have shown that the medicinal product does not inhibit CYP2D6 and is neither a substrate nor an inhibitor of P-glycoprotein.
Elimination:
In a single dose trial using a 7.5 mg dose of desloratadine, there was no effect of food (high-fat, high caloric breakfast) on the disposition of desloratadine. In another study, grapefruit juice had no effect on the disposition of desloratadine.

INDICATIONS:
Desloratadine is indicated in adults and adolescents aged 12 years or older for the relief of symptoms associated with:
– Allergic rhinitis.
– Urticaria.

CONTRAINDICATIONS:
Hypersensitivity to the active substance (loratadine), OR to any of the excipients.

SIDE EFFECT:
Fatigue, Dry mouth, Headache, Jaundice, Photosensitivity and Very rare cases of Hypersensitivity reactions.

PRECAUTION:
In the case of severe renal insufficiency, desloratadine should be used with caution. Desloratadine tablets contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Pregnancy:
indicate no malformative nor foeto/neonatal toxicity of desloratadine. Animal studies do not indicate A large amount of data on pregnant women direct or indirect harmful effects. As a precautionary measure, it is preferable to avoid the use of desloratadine during pregnancy.

Breast-feeding:
Desloratadine has been identified in breastfed newborns/infants of treated women. The effect of desloratadine on newborns/infants is unknown. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from desloratadine therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

POSOLOGY AND METHOD OF ADMINISTRATION:
Adults and adolescents 12 years of age and over:
The recommended dose of desloratadine oral solution is 10ml (5mg) oral solution once a day.

Paediatric Population:
The prescriber should be aware that most cases of rhinitis below 2 years of age are of infectious origin and there are no data supporting the treatment of infectious rhinitis with desloratadine oral solution.
Children 1 through 5 years of age: 2.5 ml (1.25 mg) desloratadine oral solution once a day.
Children 6 through 11 years of age: 5 ml (2.5 mg) desloratadine oral solution once a day.
adolescents population (12-17 years), Children (1 -11 years):

There is limited clinical trial efficacy experience with the use of desloratadine in this population.
Intermittent allergic rhinitis (presence of symptoms for less than 4 days per week or for less than 4 weeks) should be managed in accordance with the evaluation of patient’s disease history and the treatment could be discontinued after symptoms are resolved and reinitiated upon their reappearance.

In persistent allergic rhinitis (presence of symptoms for 4 days or more per week and for more than 4 weeks), continued treatment may be proposed to the patients during the allergen exposure periods.
The dose can be taken with or without food.

OVERDOSE:
In the event of overdose, consider standard measures to remove unabsorbed active substance. Symptomatic and supportive treatment is recommended.

Desloratadine is not eliminated by haemodialysis; it is not known if it is eliminated by peritoneal dialysis. PACKAGING:
100 ml amber glass bottle with an aluminum cap/carton box.
2 blisters, each contains 10 F.C.T/Carton box

GRIPPADOL

GRIPPADOL (syrup)

125 mg paracetamol, phenylephrine HCI 2.5 mg, Guaifenesin 50 mg / 5 ml

Composition and Excipients: Each 5 ml of the syrup contains:

Paracetamol 125 mg, Phenylephrine HCI 2.5 mg, Guafenesin 50 mg.

Excipients: Sorbitol 70%, Glycerin, Alcohol 96%, Propylene glycol, Sodium saccharine, Acesulfame potassium, Sodium citrate, Xanthan gum, Citric acid monohydrate, Mint flavor, Sunset yellow, Patent Blue, Purified water.

Properties:

Paracetamol is an analgesic and antipyretic.

Guaifenesin is an expectorant.

Phenylephrine Hydrochloride is a sympathomimetic decongestant.

Pharmacokinetic properties:

Paracetamol is readily absorbed from the gastrointestinal tract, it is metabolised in the liver and excreted in the urine.

Guaifenesin is rapidly absorbed after oral administration, it is rapidly metabolised and excreted in the urine.

Phenylephrine hydrochloride is irregularly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver; orally administered phenylephrine has reduced bioavailability, it is excreted in the urine almost entirely.

Indications:

Short term symptomatic relief of colds, chills and influenza including chesty coughs. Contraindications:

  • Hypersensitivity to paracetamol and/or other constituents.
  • Concomitant use of other sympathomimetic decongestants.
  • Phaeochromocytoma.
  • Closed angle glaucoma.
  • Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, heart disease or those taking tricyclic antidepressants or beta-blocking drugs and those patients who are taking or have taken, within the last two weeks, monoamine oxidase inhibitors.
  • Children under 6 years of age

Warnings and precautions:

 Duration of therapy should not exceed 5 days

  • Care is advised in the administration of paracetamol to patients with severe renal or severe hepatic impairment. The hazards of overdose are greater in those with (non-cirrhotic) alcoholic liver disease.
  • Patients suffering from chronic cough or asthma should consult a physician before taking this product.
  • Patients should stop using the product and consult a health care professional if cough lasts for more than 5 days or comes back, or is accompanied by a fever, rash or persistent headache.
  • Medical advice should be sought before taking this product in patients with these conditions: o An enlargement of the prostate gland

o Occlusive vascular disease (e.g. Raynaud’s Phenomenon)

o Cardiovascular disease

  • This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants)
  • Concomitant use of other paracetamol-containing products should be avoided. If symptoms persist the doctor should be consulted.
  • It should not be taken with other flu, cold or decongestant products or a cough suppressant. Drug Interaction:
  • If urine is collected within 24 hours of a dose of this product, a metabolite may cause a color interference with laboratory determinations of 5 hydroxyindoleacetic acid (5-HIAA) and vanillymandelic acid (VMA).

Paracetamol:

  • The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular use of paracetamol with increased risk of bleeding; occasional doses have no significant effect.
  • The hepato-toxicity of paracetamol may be potentiated by excessive intake of alcohol.
  • The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine.

Phenylephrine: It should be used with caution in combination with the following drugs as interactions have been reported:

  • Monoamine oxidase inhibitors: Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine oxidase inhibitors.

 Sympathomimetic amines: Concomitant use of phenylephrine with other sympathomimetic amines can increase the risk of cardiovascular side effects.

  • Beta-blockers and other antihypertensives: Phenylephrine may reduce the efficacy of beta- blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased. 
    • Tricyclic antidepressants: May increase the risk of cardiovascular side effects with phenylephrine.
    • Ergot alkaloids (ergotamine and methylsergide): Increased risk of ergotism.
    • Digoxin and cardiac glycosides: Increase the risk of irregular heartbeat or heart attack. Pregnancy and lactation:

    -This product should not be used during pregnancy without medical advice. The safety of guaiphenesin and phenylephrine during pregnancy has not been established.

    -Paracetamol and phenylephrine are excreted in breast milk but not in a clinically significant amount. This product should not be used whilst breast feeding without medical advice. Effects on ability to drive and use machines:

    Patients should be advised not to drive or operate machinery if affected by dizziness.

  • Side effects:Paracetamol: Due to limited clinical trial data, the frequency of these adverse events is not known. Events reported from extensive post-marketing experience at therapeutic/labelled dose are the following: Thrombocytopenia, Agranulocytosis, Anaphylaxis, Cutaneous hypersensitivity reactions including (skin rashes, angiodema and Stevens Johnson syndrome, toxic epidermal necrolysis), Bronchospasm( There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs), Hepatic dysfunction, Acute pancreatitis.Phenylephrine: The following adverse events have been observed in clinical trials and may therefore represent the most commonly occurring adverse events: Nervousness, irritability, restlessness, and excitability, Headache, dizziness, insomnia, increased blood pressure, Nausea, Vomiting, diarrhea.

    Guaifenesin: The frequency of the following events is unknown but considered likely to be rare: Allergic reactions, angioedema, anaphylactic reactions, Dyspnoea, Nausea, vomiting, abdominal discomfort, Rash, urticaria

    Dosage and Administration:

    Duration of therapy should not exceed 5 days.

    For 125 mg paracetamol, phenylephrine hcl 2.5 mg, Guaifenesin 50 mg/5 ml:

    Adults and children 12 years and over: four 5 ml spoonfuls. Repeat every four hours as necessary. Do not exceed four doses per 24 hours.

    Children 6-12 years of age: should not be given except on medical advice.

    Children under 6 years: contraindicated.

    Elderly: The normal adult dose may be taken.

    Overdose:

    Immediate medical advice should be sought in the event of an overdose, because of the risk of delayed, serious liver damage

    Paracetamol: Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (If the patient, Is on long term treatment with (carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John’s Wort or other drugs that induce liver enzymes), Regularly consumes ethanol in excess of recommended amounts or Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia).

    Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death.

    Acute renal failure with acute tubular necrosis strongly suggested by loin pain, hematuria and proteinuria may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

    Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited and may not reflect the severity of overdose or the risk of organ damage. Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol. The effectiveness of the antidote declines sharply after 8 hours.

    Phenylephrine: Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension and reflux bradycardia. In severe cases confusion, hallucinations, seizures, and arrhythmia may occur. Treatment should be as clinically appropriate. Severe hypertension may need to be treated with an alpha blocking drug such as phentolamine.

    Guaifenesin: Very large doses of guaifenesin cause nausea and vomiting. Vomiting would be treated by fluid replacement and monitoring of electrolytes.

    Storage conditions:

    Store at room temperature, (15–25) °C.

    Packaging:

    Glass bottle of 100 mL/carton box, with a measured cap.

BICLO

Nasal Spray

– Each actuation delivers 42 mcg of beclomethasone dipropionate.

– BECLO Nasal Spray provides 120 actuations (sprays).

Properties:

– Beclomethasone dipropionate, the active componant of BECLO Nasal Spray, is an anti-inflammatory steroid.

– BECLO Nasal Spray reduces the swelling and irritation in the nose, so it helps to relieve the uncomfortable symptoms.

Indications:

– BECLO Nasal Spray is indicated for the relief of the symptoms of seasonal or perennial allergic and non- allergic rhinitis.

– BECLO Nasal Spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal. The treatment should be continued for several weeks or more before a therapeutic result can be fully assessed.

Contraindications:

Hypersensitivity to any of the ingredients of BECLO Nasal Spray. Warnings:

– The replacement of a systemic corticosteroid with BECLO Nasal Spray can be accompanied by signs of adrenal insufficiency in addition to some symptoms e.g.,joint and/ or muscular pain, lassitude and depression. – Patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, too rapid decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.

– Children who are on immunosuppressant drugs are more susceptible to infections than healthy children. Chickenpox and measles, for example, can have a more serious or even fatal course in children on immunosuppressant doses of corticosteroids.

Side effects:

– Most people do not have any problems after using BECLO Nasal Spray.

– The most common side effect is irritation of the nasal mucous membranes.

– Rare cases of urticaria, rash, bronchospasm, sneezing, headache, nausea, nosebleeds and tearing eyes. Overdosage:

When BECLO Nasal Spray is used at excessive doses, it should be discontinued slowly under physician supervision.

Information for Patients:

– Patient should use BECLO Nasal Spray at regular intervals.

– Patient should take the medication as directed and should not exceed the prescribed dosage.

– Patient should contact the physician if symptoms do not improve after 3 weeks, if the condition worsen, or if sneezing or nasal irritation occurs.

Pregnancy:

– There are no adequate studies in pregnant women.

– BECLO Nasal Spray should be used during pregnancy only if the potential benefit justifies the potential risk to fetus.

Nursing Mothers:

It is not known whether beclomethasone dipropionate is excreted in human milk, because other steroids are excreted in human milk, caution should be exercised when BECLO Nasal Spray is administered to a nursing mother.

Pediatric Use:

Corticosteriods may cause a reduction in growth velocity in children and teenagers with extended use. Dosage & Administration:

– Adults and children 12 years of age and older: 1 – 2 inhalations in each nostril twice a day.

– Children 6-12 years of age: 1 inhalation in each nostril twice a day, patients not adequately responding to this dose may use 2 inhalations in each nostril.

– Not recommended for children less than 6 years of age.

– The effect of BECLO Nasal Spray is not immediate; this should be explained to the patient in order to ensure continuation of treatment.

– In the presence of excessive nasal secretion or edema of the nasal mucosa, BECLO Nasal Spray may fail

to reach the site of action; so nasal vasoconstrictor may be used during the first 3 days of BECLO Nasal Spray therapy.

Storage:

– Store between 15-30°C.

– Protect from light.

– Store away from low temperature, Do not put in refrigerator.

– Patient must cease to use this medication, 3 months after initial use of the nasal spray.

Presentation:

Plastic Bottle contains 8 g of BECLO Nasal Spray.

ELCOMED

Composition:

Each actuation delivers 50 mcg of mometasone furoate monohydrate. Elcomed nasal spray provides 120 actuations.

Description & properties:

Mometasone furoate monohydrate, the active component of Elcomed nasal spray is an anti-inflammatory corticosteroid. Elcomed nasal spray is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate calculated on the anhydrous basis.

After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 100mg of suspension

containing mometasone furoate monohydrate equivalent to 50μg of mometasone furoate calculated on the anhydrous basis.

Mechanism of Action:

Corticosteroids such as mometasone primarily reduce or prevent inflammation of the lining of the airways, reduce the allergic response to inhaled allergens, and inhibit the secretion of mucus within the airways.

Pharmacokinetics:

Mometasone furoate monohydrate administered as Elcomed nasal spray is virtually undetectable in plasma despite the use of a sensitive assay with a lower quantitation limit (LOQ) of 50 pcg/ml.

Studies have shown that any portion of a mometasone furoate dose which is swallowed and absorbed undergoes extensive metabolism to multiple metabolites.

Following intravenous administration, the effecttive plasma elimination half-life of mometasone furoate is 5.8 hours. Any absorbed drug is excreted as metabolites mostly via the bile, and to a limited extent, into the urine.

Indications:

Elcomed nasal spray is indicated for treatment of nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 3 years of age and older.

It also indicated in prophylaxis of these symptoms in adults and children 12 years of age and older.

Contraindications:

Hypersensitivity to any of the ingredients of this preparation. Nasal corticosteroids should be used with caution, if at all, in patients with tuberculous infection of respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex.

Side effects:

Side effects that may occur while using this medication include: headache, nosebleed, pink color to the mucus, sore throat, burning or irritation inside the nose and menstrual irregularities. 

Precautions:

The replacement of systemic corticosteriod with a topical

corticosteriod can be accompanied by signs of adrenal insufficiency and in addition, some patients may experience symptoms of withdrawal, such as joint and/or muscular pain, lassitude, and depression.

Too rapid decrease in systemic corticosteriod dosing may cause a severe exacerbation of these symptoms.

Very rare cases of menstrual irregularities, acneiform lesions, and cushingoid features. If such changes occur, nasal corticosteroids should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.

Persons who are on drugs, which suppress the immune system, are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in non-immune children or adults on corticosteriods. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure.

In clinical studies with Elcomed nasal spray, the development of localized infections of the nose and pharynx with candida albicans has occurred only rarely. When such an infection develops, the use of Elcomed nasal spray should be discontinued and appropriate local or systemic therapy instituted, if needed.

Rarely, immediate hypersensitivity reactions may occur after the intranasal administration of Elcomed nasal spray. Extreme rare instances of wheezing have been reported,

As with any long-term topical treatment of the nasal cavity, patients using Elcomed nasal spray over several months or longer should be examined periodically for possible changes in the nasal mucosa. Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.

Very rarely, nasal and inhaled corticosteroids have been associated with the development of glaucoma and/or cataracts. Therefore, close follow-up is warranted in patients with a change in vision and with a history of glaucoma and/or cataracts.

Pregnancy (category C):

Elcomed nasal spray should be used during pregnancy only if the potential benefits justify the potential risk to the fetus and the dose should be reduced in this case because of normal increase in cortisone level during pregnancy.

Lactation:

Caution should be used when Elcomed nasal spray is administered to nursing women.

Drug Interactions:

Systemic corticosteroids, other inhaled corticosteroids or any drugs that suppress the immune system should be avoided during treatment with Elcomed nasal spray.  

Dosage & Administration:

Adults and children 12 years of age and older:

The usual recommended dose for prophylaxis and treatment of the nasal symptoms of seasonal rhinitis and of perennial allergic rhinitis is two sprays (50μg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200μg).

Children 3-11 years: one spray in each nostril once daily.

In patients with known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with Elcomed nasal spray (200 μg/day) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.

Improvement in nasal symptoms generally occurs within 2 days after the first dose. And Maximum benefit is usually achieved within 1 to 2 weeks.

Patients should use Elcomed nasal spray daily at a regular intervals. Prior to initial use of Elcomed nasal spray, the pump must be primed by actuating ten times or until a fine sprays appear. The pump may be stored unused for up to one week without re-priming. If unused for more than one week, re-prime by actuation two times, or until a fine sprays appear.

Overdosage:

Because of low systemic bioavailability, and an absence of acute drug- related systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation.

Storage:

– Keep in temperature between(20-25)C.

– Protect from light.

Do not put in refrigerator.

Presentation:

Plastic bottle with a nasal spray contains 8 g of Elcomed nasal spray /catron box.

SEA SPRAY

Sea Spray

Nasal Spray

Each 1 ml contains Sodium Chloride 0.65%.

Properties & Indications:

■ Sea Spray provides soothing relief for dry, irritated nasal passage without stinging or burning. It restores vital moisture to provide prompt relief for crusted and inflamed nasal membranes due to chronic sinusitis, cold, low humidity, overuse of nasal decongestant drops and sprays, allergies, minor nosebleeds and other minor nasal irritations.

■ Sea Spray can be used safely with other medications indicated for the treatment of cold, allergies, and sinusitis.

Side Effects:

It can be used as often as needed without the side effects associated with overuse of decongestant nasal sprays.

Pregnancy & lactation:

No known side effects on pregnant or nursing mothers; however, it is recommended that you consult your physician.

Warnings:

The use of the same dispenser by more than one person may spread infection.

Dosage & Administration:

Infants, children and adults: spray twice in each nostril as needed or as directed by the physician.

Storage:

– Keep in temperature below 30°C.

– Keep away from Children.

Presentation:

Plastic bottle contains 20 g Sea Spray Nasal Spray/ carton box.

CYPROHEPTADINE

Indications:

Cyproheptadine is used for the symptomatic relief of hypersensitivity reactions including: Skin disorders: dermatitis, eczema, dermographia, neuroangio edema, skin

infection, and chicken pox.

Insect bites and stings.

Hey fever, allergic rhinitis, and allergic conjunctivitis (seasonal type).

Urticaria.

Urogenital pruritus.

Food and drug allergies.

Migraine and vascular headache.

Side effects:

Dry mouth, epigastric discomfort, restlessness, nausea, drowsiness, and weight gain (Cyproheptadine is a good stimulant of appetite).

Contraindications:

Hypersensitivity to Cyproheptadine. Lactation and pregnancy.

Newborn and premature infants.

Bronchial asthma, angle-closure glaucoma, urinary reaction, prostatic hypertrophy, and GI obstruction (stenosing peptic ulcer).

Drug interactions:

MAO inhibitors increase the activity of Cyproheptadine.

Cautions:

Patient must not consume alcohol or any sedatives while taking this medication. The ability to drive or operate machinery may be impaired while taking this medication.

Should be given with caution to children under 2 years of age.

Dosage & Administration:

Adults:           one tablet                                   (3 – 4) times a day (max 8 tablets daily).

Children:     (7 14) years                                 3 times a day (max 4 tablets daily).

                                                                              one tablespoon 3 times a day.

                       (2-6) years: one tablet               one teaspoon 3 times a day (max 5-teaspoon daily).

In migraine and vascular headache:

give one tablet when necessary and it can be repeated after 1⁄2 hour.

Storage:

– Keep in temperature between (15-30)°C.

Keep away from light and moisture.

Keep out of reach of Children.

Presentation:

Tablets: 2 blisters each one contains 10 Cyproheptadine tablets/carton box. Syrup: Glass bottle of 100 Cyproheptadine syrup / carton box.

Toplirect Adult

TOPLIRECT(Children-Adults)

oxomemazine, guaifenesin, paracetamol, Sodium benzoate

suppositories

KI KP Adults Toplirect suppository contains: Oxomemazine 6.6 mg, Paracetamol 133.2 mg, Guaifenesin 133.2 mg, Sodium benzoate 133.2 mg. KI KP Children Toplirect suppository contains: Oxomemazine 3.3 mg, Paracetamol 66.6 mg, Guaifenesin 66.6 mg, Sodium benzoate 66.6 mg. Excipients: Hydrogenated vegetable oil.

Pharmacologic properties:

this drug is a combination of four substances: oxomemazine, synthetic antihistamine, with antitussive and sedative properties; guaifenesin, antiseptic of the airways, fluidifying bronchial secretions and expectorant, paracetamol, analgesic and antipyretic properties, and of sodium benzoate; causing less ammonia to be produced by the body. therefore it is used in the treatment of cough of inflammatory, allergic or even infectious origin and may be associated with antibiotics or anti-inflammatories, depending on the origin of the cough. INDICATION:

Symptomatic treatment of cough (irritative, non-productive, spasmodic, dry) associated with various respiratory conditions.

CONTRAINDICATIONS:

  • Children under 2 years of age.
  • It should not be given with other product containing paracetamol.
  • It should not be given to patients allergic to the any of the components.
  • Linked to oxomemazine: respiratory insufficiency, which ever be the degree.
  • Linked to paracetamol: hepatocellular insufficiency.
  • Tell the doctor if the patients have respiratory problems, liver problems or diabetic.
  • Breast feeding.
  • Allergic reaction.

PRECAUTIONS AND WARNINGS:

  • Prior to the initiation of antitussive treatment, it is appropriate to investigate causes of cough to identify those that require etiological treatment itself, mainly asthma, cancer, endobronchial affections, among others.
  • if cough persists after administration of antitussive in usual doses, it is not advisable to increase the dosage, but to make a review of the clinical status.
  • The doctor should be informed about the pre-existing diseases, allergies and current health conditions.
  • Caution should be exercised when administering this drug to vehicle drivers or potentially dangerous machinery due to the risk of drowsiness.

Pregnancy:

The safety of this drug during pregnancy has not been established. Therefore, it is recommended that its use only be made after evaluation of the risk-benefit ratio.

Use in elderly:

There are no special warnings and recommendations on the proper use of this drug in elderly patients DRUG INTERACTIONS:

  • Linked to oxomemazine: alcoholic beverages should be avoided during treatment.
  • Tell the doctor about any medicines that the patients are taking, before starting, or during treatment.
  • This drug may potentiate CNS depressants as well as central atropines, when in combination with other anticholinergic substances (other antihistamines, imipramine, phenothiazine, antiparkinsonians, anticholinergics, atropine antispasmodics and disopyramide). This drug may interact with the following drugs: lomitapide, mipomersen, Ketoconazole, Leflunomide, Prilocaine, Probenecid, Teriflunomide.

This drug may Interfere with certain laboratory tests.

Adverse Reactions:

  • In general, the body has a high tolerance to this drug.
  • The most commonly observed adverse effect is drowsiness. more rarely, constipation and urinary retention, mental confusion, dry mouth, gastrointestinal effects(in particular digestive intolerance), tardive dyskinesias, leucopenia and agranulocytosis may be observed. • If any unpleasant reaction occurs during treatment, tell the doctor immediately.
  • Consult the doctor if the patient observes any of the following side-effects: Stomach pain, Loose motions, Vomiting, Itchy skin rash, Rash, Feeling of sickness, Skin reddening, Shortness of breath, Swollen facial features, Nausea, Abnormalities of blood cells, Less white blood cells, Acute renal tubular necrosis, Blood dyscrasias, Changes in skin color, Cold hands and feet, Confusion, Dry mouth, Fever or chills, Dry skin, Increased hunger, Increased thirst.

Dosage and administration:

  • For the suppository 6.6 mg/ 133.2 mg/ 133.2 mg/ 133.2 mg:

Adults: 1 suppository in the morning and evening.

  • For the suppository 3.3 mg/ 66.6 mg/ 66.6 mg/ 66.6 mg:

Children 2 to 12 years of age: 1 suppository three times daily.

 always respecting the schedules, the doses and the duration of the treatment.

  • Discontinuation of treatment: the treatment should not be discontinued without the knowledge of the doctor.
  • In case of missing a dose, it should be used as soon as noticing. If it is close to the time of the next dose, skip the missed dose and resume the dosing schedule. extra dose should not be used to make up for a missed dose.

OVERDOSE:

Linked to oxomemazine: the clinical picture may be characterized by depression and coma. Treatment is symptomatic and

may be necessary. artificial respiration and anticonvulsants.

Linked to paracetamol: a solid dosage causes hepatic cytolysis, with susceptibility to complete and irreversible necrosis. The clinical signs manifest usually within the first 24 hours. Treatment should be performed in specialized unit.

Storage conditions:” store at room temperature, between (15-30°C).

“Keep out of reach of children”.

How supplied: 2 plastic blister contain 10 Toplirect children /cartoon.

2 plastic blister contain 10 Toplirect Adults /cartoon.

Toplirect children

TOPLIRECT(Children-Adults)

oxomemazine, guaifenesin, paracetamol, Sodium benzoate

suppositories

KI KP Adults Toplirect suppository contains: Oxomemazine 6.6 mg, Paracetamol 133.2 mg, Guaifenesin 133.2 mg, Sodium benzoate 133.2 mg. KI KP Children Toplirect suppository contains: Oxomemazine 3.3 mg, Paracetamol 66.6 mg, Guaifenesin 66.6 mg, Sodium benzoate 66.6 mg. Excipients: Hydrogenated vegetable oil.

Pharmacologic properties:

this drug is a combination of four substances: oxomemazine, synthetic antihistamine, with antitussive and sedative properties; guaifenesin, antiseptic of the airways, fluidifying bronchial secretions and expectorant, paracetamol, analgesic and antipyretic properties, and of sodium benzoate; causing less ammonia to be produced by the body. therefore it is used in the treatment of cough of inflammatory, allergic or even infectious origin and may be associated with antibiotics or anti-inflammatories, depending on the origin of the cough. INDICATION:

Symptomatic treatment of cough (irritative, non-productive, spasmodic, dry) associated with various respiratory conditions.

CONTRAINDICATIONS:

  • Children under 2 years of age.
  • It should not be given with other product containing paracetamol.
  • It should not be given to patients allergic to the any of the components.
  • Linked to oxomemazine: respiratory insufficiency, which ever be the degree.
  • Linked to paracetamol: hepatocellular insufficiency.
  • Tell the doctor if the patients have respiratory problems, liver problems or diabetic.
  • Breast feeding.
  • Allergic reaction.

PRECAUTIONS AND WARNINGS:

  • Prior to the initiation of antitussive treatment, it is appropriate to investigate causes of cough to identify those that require etiological treatment itself, mainly asthma, cancer, endobronchial affections, among others.
  • if cough persists after administration of antitussive in usual doses, it is not advisable to increase the dosage, but to make a review of the clinical status.
  • The doctor should be informed about the pre-existing diseases, allergies and current health conditions.
  • Caution should be exercised when administering this drug to vehicle drivers or potentially dangerous machinery due to the risk of drowsiness.

Pregnancy:

The safety of this drug during pregnancy has not been established. Therefore, it is recommended that its use only be made after evaluation of the risk-benefit ratio.

Use in elderly:

There are no special warnings and recommendations on the proper use of this drug in elderly patients DRUG INTERACTIONS:

  • Linked to oxomemazine: alcoholic beverages should be avoided during treatment.
  • Tell the doctor about any medicines that the patients are taking, before starting, or during treatment.
  • This drug may potentiate CNS depressants as well as central atropines, when in combination with other anticholinergic substances (other antihistamines, imipramine, phenothiazine, antiparkinsonians, anticholinergics, atropine antispasmodics and disopyramide). This drug may interact with the following drugs: lomitapide, mipomersen, Ketoconazole, Leflunomide, Prilocaine, Probenecid, Teriflunomide.

This drug may Interfere with certain laboratory tests.

Adverse Reactions:

  • In general, the body has a high tolerance to this drug.
  • The most commonly observed adverse effect is drowsiness. more rarely, constipation and urinary retention, mental confusion, dry mouth, gastrointestinal effects(in particular digestive intolerance), tardive dyskinesias, leucopenia and agranulocytosis may be observed. • If any unpleasant reaction occurs during treatment, tell the doctor immediately.
  • Consult the doctor if the patient observes any of the following side-effects: Stomach pain, Loose motions, Vomiting, Itchy skin rash, Rash, Feeling of sickness, Skin reddening, Shortness of breath, Swollen facial features, Nausea, Abnormalities of blood cells, Less white blood cells, Acute renal tubular necrosis, Blood dyscrasias, Changes in skin color, Cold hands and feet, Confusion, Dry mouth, Fever or chills, Dry skin, Increased hunger, Increased thirst.

Dosage and administration:

  • For the suppository 6.6 mg/ 133.2 mg/ 133.2 mg/ 133.2 mg:

Adults: 1 suppository in the morning and evening.

  • For the suppository 3.3 mg/ 66.6 mg/ 66.6 mg/ 66.6 mg:

Children 2 to 12 years of age: 1 suppository three times daily.

 always respecting the schedules, the doses and the duration of the treatment.

  • Discontinuation of treatment: the treatment should not be discontinued without the knowledge of the doctor.
  • In case of missing a dose, it should be used as soon as noticing. If it is close to the time of the next dose, skip the missed dose and resume the dosing schedule. extra dose should not be used to make up for a missed dose.

OVERDOSE:

Linked to oxomemazine: the clinical picture may be characterized by depression and coma. Treatment is symptomatic and

may be necessary. artificial respiration and anticonvulsants.

Linked to paracetamol: a solid dosage causes hepatic cytolysis, with susceptibility to complete and irreversible necrosis. The clinical signs manifest usually within the first 24 hours. Treatment should be performed in specialized unit.

Storage conditions:” store at room temperature, between (15-30°C).

“Keep out of reach of children”.

How supplied: 2 plastic blister contain 10 Toplirect children /cartoon.

2 plastic blister contain 10 Toplirect Adults /cartoon.

ATAX

Hydroxyzine HCL is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation, bronchodilator activity, antihistaminic, analgesic and antiemetic effects have been demonstrated experimentally and confirmed clinically.

Clinical studies indicate that Hydroxyzine HCL in therapeutic dosage does not increase gastric secretion nor acidity, and in most cases has mild antisecretory activity. Hydroxyzine HCL is rapidly absorbed from the gastrointestinal tract and It’s clinical effects are usually noted within 15-30 minutes after oral administration. Indications:

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

– Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia. Contra-Indications:

Hydroxyzine HCL is contraindicated for patients who have shown a previous hypersensitivity to it.

Pregnancy & lactation:

Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data is available, Hydroxyzine HCL is contraindicated in early pregnancy. Nursing Mothers: It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, this medication should not be given to nursing mothers. Precautions:

The potentiating action of Hydroxyzine HCL must be considered when the drug is used in conjunction with central nervous system depressants such as narcotics, non- narcotic analgesics and barbiturates, Therefore when central nervous system depressants are administered concomitantly with Hydroxyzine HCL their dosage should be reduced.

Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking this medication.

Patients should be advised against the simultaneous use of other CNS depressant drug, and cautioned that the effect of alcohol may be increased.

Adverse reactions:

Side effects reported with the administration of this medication are usually mild and transitory in nature.

The most common side effects: dry mouth and drowsiness.

Respiratory depression, involuntary motor activity including tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Overdosage:

The most common manifestation of this medication overdosage is hypersedation.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended.

General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.

Dosage & Adminstration:

For symptomatic relief of anxiety and tension in:

Children under 6 years: 50 mg daily in divided doses. Childers over 6 years: 50 – 100 mg in divided doses.

Adults: 50 100 mg (4 times daily).

For use in the management of pruritus due to allergic conditions:

Children under 6 years: 50 mg in divided doses.

Children over 6 years: 50 – 100 mg daily in divided doses.

Adults: 25 mg (3 or 4 times daily).

As a sedative when used as a premedication and following general anesthesia: 50 100 mg in adults, and 0.6 mg/kg in children.

As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

Storage:

Store below 25 °C.

Do not despense without a medical prescription.

Presentation:

– ATAX-Mediotic tablets: 2 blisters each one contians 10 coated tablets / carton box.

– ATAX-Mediotic syurp: Glass bottle of 100ml / carton box.

BELORAMINE

Indications:

All allergy conditions: rhinitis (especially seasonal type), hay fever, conjunctivitis, and urticaria.

Drug allergies: after taking medications for the treatment of cases that is accompanied with urticaria.

Skin disorders: such as atopic dermatitis, contact dermatitis, acute urticaria, insect bites & stings and allergic rashes.

Motion sickness.

Cautions:

The effects of alcohol and C.N. S. depressants may be increased.

Patients should be warned that ability to drive or operate machinery may be impaired.

Drug Interactions:

Antiepileptics.

Side Effects:

Rare in usual doses.

Sedation, dizziness, tinnitus, in-coordination, headache, and dry mouth.

Contraindications:

Glaucoma (To be given with caution if necessary).

Premature born babies and new borns.

Dosage & administration:

Dosage

0.5mg chlorpheniramie maleate (1.25ml syrup) 0.5mg chlorpheniramie maleate (1.25ml syrup)

Frequency (Times/day) 3-4 times daily

Twice daily 3-4 times daily

6 – 12 years

Over 12 years

1mg chlorpheniramie maleate (2.5ml syrup) 1 tablet

3-4 times daily

2-3 times daily

Storage:

Store at temperature Under 25°C.

– Keep out of reach of children.

Protect from light and moisture.

Presentation:

Beloramine Tablets: 2 blisters each one contains 10 Beloramine tablets/carton box.

– Beloramine Syrup: Glass bottle of 100ml Beloramine syrup/ carton box.

CYPROHEPTADINE

 

Indications:

Cyproheptadine is used for the symptomatic relief of hypersensitivity reactions including: Skin disorders: dermatitis, eczema, dermographia, neuroangio edema, skin

infection, and chicken pox.

Insect bites and stings.

Hey fever, allergic rhinitis, and allergic conjunctivitis (seasonal type).

Urticaria.

Urogenital pruritus.

Food and drug allergies.

Migraine and vascular headache.

Side effects:

Dry mouth, epigastric discomfort, restlessness, nausea, drowsiness, and weight gain (Cyproheptadine is a good stimulant of appetite).

Contraindications:

Hypersensitivity to Cyproheptadine. Lactation and pregnancy.

Newborn and premature infants.

Bronchial asthma, angle-closure glaucoma, urinary reaction, prostatic hypertrophy, and GI obstruction (stenosing peptic ulcer).

Drug interactions:

MAO inhibitors increase the activity of Cyproheptadine.

Cautions:

Patient must not consume alcohol or any sedatives while taking this medication. The ability to drive or operate machinery may be impaired while taking this medication.

Should be given with caution to children under 2 years of age.

Dosage & Administration:

Adults:           one tablet                                   (3 – 4) times a day (max 8 tablets daily).

Children:     (7 14) years                                 3 times a day (max 4 tablets daily).

                                                                              one tablespoon 3 times a day.

                       (2-6) years: one tablet               one teaspoon 3 times a day (max 5-teaspoon daily).

In migraine and vascular headache:

give one tablet when necessary and it can be repeated after 1⁄2 hour.

Storage:

– Keep in temperature between (15-30)°C.

Keep away from light and moisture.

Keep out of reach of Children.

Presentation:

Tablets: 2 blisters each one contains 10 Cyproheptadine tablets/carton box. Syrup: Glass bottle of 100 Cyproheptadine syrup / carton box.

GRIPPAMOL

Composition: Tablets

Each tablet contains: Paracetamol 350 mg, Ascorbic acide (Vitamin C) 150 mg, Caffeine 25 mg, Chlorpheniramine maleate 2.5 mg.

Properties:

GRIPPAMOL exhibits a combined effect of 4 drugs.

– It has a decongestant action on the upper respiratory tract

(chlorpheniramine maleate) is an antihistamine for H1 central and peripheral receptors and an analgesic, antipyretic action (Paracetamol) therefore, it is suitable to relief the cold symptoms of upper respiratory tract.

-The combination of Vitamin C with caffeine (Centeral Nervous System stimulant) increases the muscular and mental activity.

– It is advisable to use an antibiotic in the case of a grippe associated with bacterial infection.

Indications:

GRIPPAMOL is indicated to treat the symptoms of nasal congestion and

obstruction, rhinorrhea, fever, headache, acute congestive or allergic rhinopharyngitis, rhinitis, sinusitis, pharyngitis and catarrh.

Contraindications:

– Patients allergic to any drug components.

– Severe hepatic failure.

Closed angle glaucoma.

– Patients with the risk of renal retention (urethra-prostatic problems). Children less than 5 years old.

Side effect:

Insomnia, gastrointestinal disturbances, dry mouth and frequently skin allergic reactions.

Drug interactions:

Do not take GRIPPAMOL with antihypertensive agents or CNS inhibitors. Warnings:

– Avoide driving a motor vehicle or operating heavy machinery.

– Avoide alcoholic beverages for the sedative effect of chlorpheniramine maleate might be increased.

Do not exceed the prescribed dose.

Dosage and Administration:

– Adults: treatment of acute rhinopharyngitis, rhinitis: one tablet 3 times daily. Treatment of acute grippe: 1-2 tablets 2-3 times daily.

– Children 10-15 years: 1-2 tablets daily, or as the doctor’s instructions.

Children 5-10 years: 2-1 tablet daily, or as the doctor’s instructions.

Storage:

– Keep in temperature below 25°C.

– Keep away from light and moisture.

– Keep away from Children.

Presentation: 2 blisters each one contains 10 tablets / catron box.

HYDRAMINE

Excipients: Lactose Monohydrate, Starch, Talc, Magnesium Stearate, Aerosil, CrossCarmellose Sodium, Povidone, Deionized Water, Yellow Tincture.

PHARMACOKINETICS:

Dimenhydrinate is well absorbed from the gastro-intestinal tract after oral dosing with extensive first-pass effect. The drug is metabolised in the liver and excreted usually as metabolites in the urine. The drug is highly bound to plasma proteins and is widely distributed in the body. Following oral administration, the effects develop in about 30 minutes and are maximalwithin 1-2 hours and last for 3-6 hours.

INDICATIONS:

For prevention and treatment of these symptoms associated with motion sickness:

  • nausea
  • vomiting
  • dizziness

Dimenhydrinate is used mainly as an anti-emetic in the prevention and treatment of motion sickness; irradiation sickness, postoperative vomiting, drug-induced nausea and vomiting, and the symptomatic treatment of nausea and vertigo due to Meniere’s disease and other labyrinthine disturbances.

CONTRAINDICATIONS:

Sensitivity to Dimenhydrinate or any of the other ingredients.

  • In patients with porphyria.

Children under 2 years old.

WARNINS AND PERCAUTIONS:

Should not be used for children under 2 years of age unless directed by a doctor. Patients should advise a doctor before use if they have: A breathing problem such as emphysema or chronic bronchitis.

■ Glaucoma.

Trouble urinating due to an enlarged prostate gland.

Patients should advise a doctor before use if they are:

  • Taking sedatives or tranquilizers.

When using this product:

  • Marked drowsiness may occur.
  • Alcoholic drinks should be avoided.

Dizziness may be increased by alcohol, sedatives, and tranquilizers.

Careful should be taken when driving a motor vehicle or operating machinery. Dimenhydrinate should be used with caution in patients with: Epilepsy.

Prostatic hypertrophy or urinary retention.

Glaucoma.

Hepatic diseases.

Pyloroduodenal obstruction.

In patients with renal impairment, a reduction in the dose of any antihistamine (e.g. dimenhydrinate) may be necessary.

Use in children under 6 years old should only be under professional advice.

dimenhydrinate should not be taken with cough and cold medicines in children aged 2-6 years old.

Children and the elderly are more susceptible to the side effects.

It has been suggested that Dimenhydrinate could mask warning symptoms of damagecaused by ototoxic drugs such as the amino-glycoside antibiotics.

Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Pregnancy or breast-feeding:

-Dimenhydrinate should not be used in pregnancy unless the physician considers it is essential. 

-Dimenhydrinate is excreted in breast milk to such an extent that effects on the suckling child are likely if therapeutic doses of Dimenhydrinate are administered to breast-feeding women. Effects on ability to drive and use machines:

Patients undergoing treatment with Dimenhydrmnate should not take charge of vehicles, other means of transport or machinery where loss of attention may lead to accidents because Dimenhydrinate may cause drowsiness and dullingof mental alertness.

DRUG INTERACTIONS:

-Dimenhydrinate will interact with anticholinergic, anti-depressant (tricyclic and MAOIs) and anti-Parkinson drugs such as Trihexyphenidyl, increasing the anticholinergic side effects, dry mouth, urine retention, confusion, etc.

-The effects of Betahistine may be antagonized.

-Sedating antihistamines may enhance the sedative effects of CNS depressants including alcohol, other sedating antihistamines, barbiturates, hypnotics, opioids, anxiolytic sedatives and antipsychotics.

It is important that the dose of Neperidine, Morphine or other narcotic analgesics andof barbiturates be reduced by 1/4 or 2 when used concomitantly.

ADVERSE REACTIONS:

Adverse effects with Dimenhydrinate may vary in incidence and severity from patient to patient. The most common effect sedation which may vary from slight drowsiness to deep sleep. The drug may be associated with inability to concentrate, lassitude, dizziness, hypotension, muscular weakness and in co-ordination. When they do occur the sedative effects may diminish after a few days.

DOSAGE AND ADMINISTRATION:

To prevent motion sickness, the first dose should be taken 1⁄2 to 1 hour before starting activity to prevent or treat motion sickness:

Adults and children 12 years and over:

1 to 2 tables every 4-6 hours.

Should not take more than 8 tablets in 24 hours, or as directed by a doctor.

Children 6 to under 12 years:

1⁄2 to 1 tablet every 6-8 hours.

Should not give more than 3 tablets in 24 hours, or as directed by a doctor Children 2 to under 6 years:

1⁄2 tablet every 6-8 hours.

Should not give more than 1 1⁄2 tablets in 24 hours, or as directed by a doctor. Contraindicated for children under 2 years.

Elderly: Same as adult dose.

OVERDOSE:

In the case of severe overdosage, the stomach should be emptied by gastriclavage. Emetics should not be used.

The patient should be kept quiet, particularly in the case of children, to minimize the excitation which occurs.

Convulsions may be controlled with Diazepam preferably given intravenously. Since Dimenhydrinate is rapidly metabolised with only traces being in the urine, diuresis is of little, if any, value.

PACKAGING: 10 blisters, each contains 10 film-coated tablets/carton box.

STORAGE CONDITIONS:

Protect from light and moisture.

Store at room temperature, between (15-30) °C.

ATAX

Hydroxyzine HCL is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system. Primary skeletal muscle relaxation, bronchodilator activity, antihistaminic, analgesic and antiemetic effects have been demonstrated experimentally and confirmed clinically.

Clinical studies indicate that Hydroxyzine HCL in therapeutic dosage does not increase gastric secretion nor acidity, and in most cases has mild antisecretory activity. Hydroxyzine HCL is rapidly absorbed from the gastrointestinal tract and It’s clinical effects are usually noted within 15-30 minutes after oral administration. Indications:

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

– Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus. As a sedative when used as premedication and following general anesthesia. Contra-Indications:

Hydroxyzine HCL is contraindicated for patients who have shown a previous hypersensitivity to it.

Pregnancy & lactation:

Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data is available, Hydroxyzine HCL is contraindicated in early pregnancy. Nursing Mothers: It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, this medication should not be given to nursing mothers. Precautions:

The potentiating action of Hydroxyzine HCL must be considered when the drug is used in conjunction with central nervous system depressants such as narcotics, non- narcotic analgesics and barbiturates, Therefore when central nervous system depressants are administered concomitantly with Hydroxyzine HCL their dosage should be reduced.

Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking this medication.

Patients should be advised against the simultaneous use of other CNS depressant drug, and cautioned that the effect of alcohol may be increased.

Adverse reactions:

Side effects reported with the administration of this medication are usually mild and transitory in nature.

The most common side effects: dry mouth and drowsiness.

Respiratory depression, involuntary motor activity including tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Overdosage:

The most common manifestation of this medication overdosage is hypersedation.

If vomiting has not occurred spontaneously, it should be induced. Immediate gastric lavage is also recommended.

General supportive care, including frequent monitoring of the vital signs and close observation of the patient, is indicated.

Dosage & Adminstration:

For symptomatic relief of anxiety and tension in:

Children under 6 years: 50 mg daily in divided doses. Childers over 6 years: 50 – 100 mg in divided doses.

Adults: 50 100 mg (4 times daily).

For use in the management of pruritus due to allergic conditions:

Children under 6 years: 50 mg in divided doses.

Children over 6 years: 50 – 100 mg daily in divided doses.

Adults: 25 mg (3 or 4 times daily).

As a sedative when used as a premedication and following general anesthesia: 50 100 mg in adults, and 0.6 mg/kg in children.

As with all medications, the dosage should be adjusted according to the patient’s response to therapy.

Storage:

Store below 25 °C.

Do not despense without a medical prescription.

Presentation:

– ATAX-Mediotic tablets: 2 blisters each one contians 10 coated tablets / carton box.

– ATAX-Mediotic syurp: Glass bottle of 100ml / carton box.

BELORAMINE

Indications:

All allergy conditions: rhinitis (especially seasonal type), hay fever, conjunctivitis, and urticaria.

Drug allergies: after taking medications for the treatment of cases that is accompanied with urticaria.

Skin disorders: such as atopic dermatitis, contact dermatitis, acute urticaria, insect bites & stings and allergic rashes.

Motion sickness.

Cautions:

The effects of alcohol and C.N. S. depressants may be increased.

Patients should be warned that ability to drive or operate machinery may be impaired.

Drug Interactions:

Antiepileptics.

Side Effects:

Rare in usual doses.

Sedation, dizziness, tinnitus, in-coordination, headache, and dry mouth.

Contraindications:

Glaucoma (To be given with caution if necessary).

Premature born babies and new borns.

Dosage & administration:

Dosage

0.5mg chlorpheniramie maleate (1.25ml syrup) 0.5mg chlorpheniramie maleate (1.25ml syrup)

Frequency (Times/day) 3-4 times daily

Twice daily 3-4 times daily

6 – 12 years

Over 12 years

1mg chlorpheniramie maleate (2.5ml syrup) 1 tablet

3-4 times daily

2-3 times daily

Storage:

Store at temperature Under 25°C.

– Keep out of reach of children.

Protect from light and moisture.

Presentation:

Beloramine Tablets: 2 blisters each one contains 10 Beloramine tablets/carton box.

– Beloramine Syrup: Glass bottle of 100ml Beloramine syrup/ carton box.