1. ASTEMIZOLUM (30 tab/10 mg of astemizole in tablet)
2. CELECTOLUM (50 tab/200mg of celiprolol in tablet)
3. LORATADINUM (50 tab/10 mg of loratadine in tablet)
4. TRIAMIN (10 ml/ 10 mg of triamcinolone acetonide in ml)
5. FEXOFENODINUM (20 tab/180 mg of fexofenadine in tablet)
ASTEMIZOLUM (30 tab/10 mg of astemizole in tablet)
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Use: It is prescribed for allergic rhinitis and chronic idiopathic urticaria.
Category: Antihistamines
Side effects:
An allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives)
An irregular heartbeat
Fainting
Seizures
Less serious side effect:
Drowsiness or dizziness
Headache
Nervousness
Nausea, diarrhea, or abdominal discomfort
Dry mouth
Dry skin or itchiness
Dosage:
Adult: PO- The recommended dose is 10 mg once daily.
Astemizole has been given in an oral dose of 10 mg once daily,
or 5 mg daily in children aged 6 to 12 years. These doses must
not be exceeded because of the risk of cardiac arrhythmias with
higher doses.
The active metabolite of astemizole, tecastemizole (norastemizole)
has been investigated for the treatment of allergic rhinitis.
Precautions:
Patients with history of prostate enlargement, urinary retention, increased eye pressure, intestinal obstruction, liver diseases, epilepsy.
Children
Elderly
Pregnancy
Breastfeeding
How to take:
It comes as a tablet to take by mouth, on an empty stomach (1 hour before or 2 hours after meals).
Contra indications: Patients with bruising.
CELECTOLUM (50 tab/200mg of celiprolol in tablet)
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Adults:
The initial dose is 200mg orally taken once daily with a glass of water. Celectol should preferably be taken first thing in the morning, 30 minutes before food or 2 hours after a meal. If response is inadequate, the dose may be increased to 400 mg once daily according to the therapeutic response.
In hypertensive patients additional treatment with other anti-hypertensive agents is possible, in particular with diuretics. When a combination is initiated an increased monitoring the blood pressure is recommended.
Elderly patients:
Dosage as for adults.
However close monitoring of elderly patients should be exercised, as renal and hepatic functions may be decreased in this population.
Children:
Not recommended.
Patients with renal insufficiency.
Contraindications:
As with other beta-adrenoceptor antagonists, celiprolol should not be used in cases of cardiogenic shock, uncontrolled heart failure, sick-sinus syndrome, (including sino-atrial block), second or third degree heart block, severe bradycardia (<45-50 beats per minute), severe renal impairment with creatinine clearance less than 15ml per minute, acute episodes of asthma, untreated phaeochromocytoma, metabolic acidosis, hypotension, hypersensitivity to the active substance or any of the excipients, or severe peripheral arterial circulatory disturbances.
Celectol tablets should not be prescribed for patients being treated with theophylline
Pregnancy and lactation:
The safety of this medicinal product for use in human pregnancy has not been established. An evaluation of experimental animal studies does not indicate direct or indirect harmful effects with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and post-natal development.
However, beta-adrenoceptor blocking drugs in general have been associated with reduced placental perfusion, which may result in intrauterine foetal death, immature and premature deliveries. Celiprolol should therefore not be used during pregnancy unless there is no safer alternative.
In the newborn of treated mothers, beta-blocking activity persists for several days after birth and this may result in an increased risk of cardiac and pulmonary complications in the neonate in the post natal period. In addition, adverse effects (especially hypoglycaemia, bradycardia and respiratory distress) may occur in foetus and neonate.. Therefore close monitoring of the neonate is recommended for the first 3 to 5 days of life.
Most beta blockers will pass into breast milk, although to variable extents. The use of Celectol is therefore not recommended in breast-feeding mothers.
Undesirable effects:
Beta-adrenoceptor blockers may mask the symptoms of thyrotoxicosis or hypoglycaemia (in particular, tachycardia).
Occasional side effects, which are usually mild and transient have occurred. These include headache, hot flushes, asthenia, dizziness, fatigue, somnolence and insomnia (sleep disturbances). Additional side effects associated with beta-2 agonist activity, tremor and palpitations, have been reported. These effects usually do not require withdrawal of therapy. Depression and hypersensitivity pneumonitis have been reported rarely.
Bronchospasm, skin rashes and/or visual disturbances have been reported in association with the use of beta blockers. Celectol should be discontinued if these effects occur.
In addition, the following undesirable effects, listed by body system, are generally attributable to the pharmacological activity of beta-adrenergic blockers:
Cardiovascular: bradycardia, slowed A-V conduction, hypotension, heart failure, cold and cyanotic extremities. In susceptible patients: precipitation of existing A-V block, exacerbation of intermittent claudication, Raynaud's disease or syndrome.
CNS: confusion, hallucinations, psychoses, nightmares.
Neurological: paraesthesia.
Respiratory: bronchospasm may occur in patients with bronchial asthma or with a history of bronchial complaints. Dyspnoea and interstitial pneumonitis have also been rarely reported.
Gastro-intestinal: vomiting, diarrhoea, nausea and gastralgia.
Integumentary: skin disorders (cutaneous effects including psoriasiform rash), dry eyes.
Reproductive system: Libido decrease, male impotency.
Eye: Visual disturbances have been reported including xerophthalamias.
Hepatobiliary: Increase in transaminases.
Metabolism and Nutritional: Hypoglycaemia, hyperglycemia.
Collagen disorders: Antinuclear antibodies have been observed, exceptional and reversible lupus syndrome.
Others: An increase in ANA (antinuclear antibodies) has been reported, although its clinical relevance is not clear.
LORATADINUM (50 tab/10 mg of loratadine in tablet)
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Therapeutic indications:
Loratadine 10mg Orodispersible Tablet is indicated for the symptomatic treatment of allergic rhinitis (AR) and chronic idiopathic urticaria (CIU).
Contraindications:
Hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use:
Loratadine should be administered with caution in patients with severe hepatic impairment. This product contains lactose and sorbitol. Patients with rare hereditary problems of fructose intolerance, galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
This product contains aspartame. Aspartame is a source of phenylalanine, which may be harmful for people with phenylketonuria.
The administration of loratadine should be discontinued at least 48 hours before skin tests since antihistamines may prevent or reduce otherwise positive reactions to dermal reactivity index.
Posology and method of administration:
Loratadine 10mg Orodispersible Tablets should be handled with caution and with dry hands only.
Loratadine 10mg Orodispersible Tablets are intended for oral use.
The tablet shall be put on the tongue and wait until it is thoroughly disintegrated. Water or other liquid is not needed to swallow the dose.
The orodispersible tablet may be taken without regard to mealtime.
Adults and children over 12 years of age
10 mg once daily (one orodispersible tablet once daily).
Paediatric population
Children 2 to 12 years of age with body weight more than 30 kg: 10 mg once daily (one orodispersible tablet once daily).
The 10 mg strength orodispersible tablet is not appropriate in children with a body weight less than 30 kg.
Efficacy and safety of loratadine in children under 2 years of age has not been established.
Severe Hepatic impairment
Patients with severe hepatic impairment should be administered a lower initial dose because they may have reduced clearance of loratadine. An initial dose of 10 mg every other day is recommended for adults and children weighing more than 30 kg.
Elderly or Renal impairment
No dosage adjustments are required in the elderly or in patients with renal insufficiency.
Pregnancy and lactation:
Loratadine was not teratogenic in animal studies. The safe use of loratadine during pregnancy has not been established. The use of loratadine during pregnancy is therefore not recommended.
Loratadine is excreted in breast milk, therefore the use of loratadine is not recommended in breastfeeding women.
Undesirable effects:
In clinical trials in a paediatric population, children aged 2 through 12 years, common adverse reactions reported in excess of placebo were headache (2.7%), nervousness (2.3%), and fatigue (1%).
In clinical trials involving adults and adolescents in a range of indications including AR and CIU, at the recommended dose of 10 mg daily, adverse reactions with loratadine were reported in 2 % of patients in excess of those treated with placebo.
The most frequent adverse reactions reported in excess of placebo were somnolence (1.2%), headache (0.6%), increased appetite (0.5%) and insomnia (0.1%).
Other adverse reactions reported very rarely during the post-marketing period are listed in the following table.
Immune system disorders:
Anaphylaxis
Nervous system disorders:
Dizziness
Cardiac disorders:
Tachycardia, palpitation
Gastrointestinal disorders:
Nausea, dry mouth, gastritis
Hepatobiliary disorders:
Abnormal hepatic function
Skin and subcutaneous tissue disorders:
General disorders and administration site conditions:
Fatigue
TRIAMIN (10 ml/ 10 mg of triamcinolone acetonide in ml)
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Therapeutic indications:
Intra-articular use: for alleviating the joint pain, swelling and stiffness associated with rheumatoid arthritis and osteoarthrosis, with an inflammatory component; also for bursitis, epicondylitis, and tenosynovitis.
Intradermal use: for lichen simplex chronicus (neuro-dermatitis), granuloma annulare, lichen planus, keloids, alopecia areata and hypertrophic scars.
Posology and method of administration:
Adcortyl is for intra-articular or intra-dermal injection ONLY. The safety and efficacy of administration by other routes has yet to be established. Strict aseptic precautions should be observed. Since the duration of effect is variable, subsequent doses should be given when symptoms recur and not at set intervals.
Adults: The dose of Adcortyl injection for intra-articular administration, and injection into tendon sheaths and bursae, is dependent on the size of the joint to be treated and on the severity of the condition. Doses of 2.5-5mg (0.25-0.5ml) for smaller joints and 5-15mg (0.5-1.5ml) for larger joints usually alleviate the symptoms. Triamcinolone acetonide 40mg/ml (Kenalog) is available to facilitate administration of larger doses. (See Precautions re Achilles tendon).
Intradermal dosage is usually 2-3mg (0.2-0.3ml), depending on the size of the lesion. No more than 5mg (0.5ml) should be injected at any one site. If several sites are injected the total dosage administered should not exceed 30mg (3ml). The injection may be repeated if necessary, at one or two week intervals.
Elderly: Treatment of elderly patients, particularly if long term, should be planned bearing in mind the more serious consequences of the common side effects of corticosteroids in old age, especially osteoporosis, diabetes, hypertension, hypokalaemia, susceptibility to infection and thinning of the skin. Close supervision is required to avoid life-threatening reactions.
Children: Adcortyl is not recommended in children under 6 years. Adcortyl intra-articular/intradermal may be used in older children in suitably adjusted dosages. Growth and development of children on prolonged corticosteroid therapy should be carefully observed. Caution should be used in the event of exposure to chickenpox, measles or other communicable diseases.
Contraindications:
Hypersensitivity to any of the ingredients.
Systemic infections unless specific anti-infective therapy is employed.
Administration by intravenous, intrathecal, epidural or intraocular injection.
Effects on ability to drive and use machines:
None known.
Interaction with other medicinal products and other forms of interaction:
Amphotericin B injection and potassium-depleting agents: Patients should be observed for hypokalaemia.
Anticholinesterases: Effects of anticholinesterase agent may be antagonised.
Anticoagulants, oral: Corticosteroids may potentiate or decrease anticoagulant action. Patients receiving oral anticoagulants and corticosteroids should therefore be closely monitored.
Antidiabetics: Corticosteroids may increase blood glucose; diabetic control should be monitored, especially when corticosteroids are initiated, discontinued, or changed in dosage.
Antihypertensives, including diuretics: corticosteroids antagonise the effects of antihypertensives and diuretics. The hypokalaemic effect of diuretics, including acetazolamide, is enhanced.
Anti-tubercular drugs: Isoniazid serum concentrations may be decreased.
Cyclosporin: Monitor for evidence of increased toxicity of cyclosporin when the two are used concurrently.
Digitalis glycosides: Co-administration may enhance the possibility of digitalis toxicity.
Oestrogens, including oral contraceptives: Corticosteroid half-life and concentration may be increased and clearance decreased.
Hepatic Enzyme Inducers (e.g. barbiturates, phenytoin, carbamazepine, rifampicin, primidone, aminoglutethimide): There may be increased metabolic clearance of Adcortyl. Patients should be carefully observed for possible diminished effect of steroid, and the dosage should be adjusted accordingly.
Human growth hormone: The growth-promoting effect may be inhibited.
Ketoconazole: Corticosteroid clearance may be decreased, resulting in increased effects.
Nondepolarising muscle relaxants: Corticosteroids may decrease or enhance the neuromuscular blocking action.
Nonsteroidal anti-inflammatory agents (NSAIDS): Corticosteroids may increase the incidence and/or severity of GI bleeding and ulceration associated with NSAIDS. Also, corticosteroids can reduce serum salicylate levels and therefore decrease their effectiveness. Conversely, discontinuing corticosteroids during high-dose salicylate therapy may result in salicylate toxicity. Aspirin should be used cautiously in conjunction with corticosteroids in patients with hypoprothrombinaemia.
Thyroid drugs: Metabolic clearance of adrenocorticoids is decreased in hypothyroid patients and increased in hyperthyroid patients. Changes in thyroid status of the patient may necessitate adjustment in adrenocorticoid dosage.
Vaccines: Neurological complications and lack of antibody response may occur when patients taking corticosteroids are vaccinated
FEXOFENODINUM (20 tab/180 mg of fexofenadine in tablet)
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Therapeutic indications:
Relief of symptoms associated with chronic idiopathic urticaria.
Posology and method of administration:
Adults and children aged 12 years and over
The recommended dose of fexofenadine hydrochloride for adults and children aged 12 years and over is 180 mg once daily taken before a meal.
Fexofenadine is a pharmacologically active metabolite of terfenadine.
Children under 12 years of age
The efficacy and safety of fexofenadine hydrochloride has not been studied in children under 12.
Special risk groups
Studies in special risk groups (elderly, renally or hepatically impaired patients) indicate that it is not necessary to adjust the dose of fexofenadine hydrochloride in these patients.
Contraindications:
In patients with known hypersensitivity to the active substance or to any of the excipients.
Special warnings and precautions for use:
As with most new drugs there is only limited data in the elderly and renally or hepatically impaired patients.
Fexofenadine hydrochloride should be administered with care in these special groups.
Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a drug class, have been associated with the adverse events, tachycardia and palpitations (see section 4.8).
Interaction with other medicinal products and other forms of interaction:
Fexofenadine does not undergo hepatic biofransforrnation and therefore will not interact with other drugs through hepatic mechanisms. Coadministration of fexofenadine hydrochloride with erythromycin or ketoconazole has been found to result in a 2-3 times increase in the level of fexofenadine in plasma. The changes were not accompanied by any effects on the QT interval and were not associated with any increase in adverse events compared to the drugs given singly.
Animal studies have shown that the increase in plasma levels of fexofenadine observed after coadministration of erythromycin or ketoconazole, appears to be due to an increase in gastrointestinal absorption and either a decrease in biliary excretion or gastrointestinal secretion, respectively.
No interaction between fexofenadine and omeprazole has been observed. However, the administration of an antacid containing aluminium and magnesium hydroxide gels 15 minutes prior to fexofenadine hydrochloride caused a reduction in bioavailability, most likely due to binding in the gastrointestinal tract. It is advisable to leave 2 hours between administration of fexofenadine hydrochloride and aluminium and magnesium hydroxide containing antacids.
Pregnancy and lactation:
Pregnancy
There are no adequate data from the use of fexofenadine hydrochloride in pregnant women.
Limited animal studies do not indicate direct or indirect harmful effects with respect to effects on pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Fexofenadine hydrochloride should not be used during pregnancy unless clearly necessary.
Lactation
There are no data on the content of human milk after administering fexofenadine hydrochloride. However, when terfenadine was administered to nursing mothers fexofenadine was found to cross into human breast milk. Therefore fexofenadine hydrochloride is not recommended for mothers breast feeding their babies.
Effects on ability to drive and use machines:
On the basis of the pharmacodynamic profile and reported adverse events it is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective tests, Fexofenadine has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks thatrequire concentration. However, in order to identify sensitive people who have an unusual reaction to drugs, it is advisable to check the individual response before driving or performing complicated tasks.
Undesirable effects:
In controlled clinical trials in adults the most commonly reported adverse events related to treatment were headache (7.3%), drowsiness (2.3%), nausea (1.5%) and dizziness (1.5%). The incidence of these events observed with fexofenadine was similar to that observed with placebo.
Events related to treatment that have been reported with an incidence of less than 1% include: fatigue, insomnia, nervousness and sleep disorders or paroniria, such as nightmares and tachycardia, palpitations and diarrhoea. In rare cases, rash, urticaria, pruritus, and hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnoea, flushing and systemic anaphylaxis have also been reported.
Overdose:
Symptoms of dizziness, drowsiness, fatigue and dry mouth have been reported with overdose of fexofenadine hydrochloride. Single doses up to 800 mg, and doses up to 690 mg twice daily for 1 month, or 240 mg once daily for 1 year have been administered to healthy subjects without the development of clinically significant adverse events. The maximum tolerated dose of fexofenadine hydrochloride has not been established.
Standard measures should be considered to remove any unabsorbed fexofenadine. Symptomatic and supportive treatment is recommended. Haemodialysis does not effectively remove fexofenadine hydrochloride from blood.