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Celestamine NS (Betamethasone, Loratadine)

Active Ingredient: Betamethasone, Loratadine
Dosage: 5 mg/0,25 mg
Route of Administration: Oral
Dosage Form: Tablets
Quantity per package: 10, 20, 30, 60 tablets per pack
Availability: Out of Stock

Why Celestamine NS Is Not Sold in the USA

Celestamine NS faces limited usage in the United States, primarily attributed to stringent regulations imposed by the FDA concerning the combination of corticosteroids and antihistamines in a single formulation. The FDA’s cautious approach stems from concerns regarding the potential side effects associated with long-term corticosteroid usage, emphasizing the need for thorough safety evaluations before approval. Additionally, the American market offers a plethora of alternative medications that can be tailored more precisely to individual patient needs, further diminishing the demand for Celestamine NS. These factors collectively contribute to its limited adoption in the USA.

Alternative Drugs Sold in the USA

For similar symptoms and diseases treated by Celestamine NS, here are some drugs available in the USA.

For Inflammatory Skin Conditions (e.g., Psoriasis, Dermatitis)

For General Antihistamine Effects (e.g., Allergic Dermatitis)

For Both Anti-Inflammatory and Antihistamine Needs

These alternatives are typically used in separate formulations in the U.S., allowing for specific dosing adjustments and targeted therapy to minimize potential side effects and maximize therapeutic benefits.

What is Celestamine NS?

Celestamine NS is an oral corticosteroid that treats skin conditions such as psoriasis, dermatitis of different types (atopic seborrhea and neurodermatitis). In general, the drug is used as an anti-inflammatory and can also reduce pain. It is recommended for respiratory, serious dermatological and ocular allergies. Betamethasone reduces inflammation, redness, and swelling associated with conditions like psoriasis and various types of dermatitis, including atopic, seborrheic, and neurodermatitis. Loratadine, on the other hand, helps alleviate itching and allergic reactions by blocking the action of histamine.

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Indications

Celestamine NS is an antiallergic, steroidal anti-inflammatory and antihistamine medication. The tablets are recommended when adjuvant treatment with a systemic corticosteroid agent is necessary for the relief of severe symptoms of atopic dermatitis, angioedema, urticaria, seasonal and perennial allergic rhinitis, food and drug allergic reactions, seborrheic dermatitis, neurodermatitis, allergic asthma, allergic eye manifestations such as conjunctivitis and iridocyclitis and allergic reactions to insect bites.

Where Is Celestamine NS Popular?

Celestamine NS enjoys significant popularity in countries facing a high prevalence of dermatological issues necessitating both anti-inflammatory and antihistaminic treatment. For instance, in Latin American nations such as Mexico and Brazil, where variable climate conditions often worsen skin conditions, Celestamine NS is favored. Similarly, in Southeast Asian regions like the Philippines and Indonesia, where high humidity exacerbates dermatological problems, effective remedies like Celestamine NS are in demand.

The rationale behind its widespread usage in these regions lies in the combination of an antihistamine with a corticosteroid within a single medication. This combination is highly esteemed for its efficacy in addressing complex skin conditions that may not adequately respond to monotherapy. Moreover, accessibility and the familiarity of the product also contribute to its widespread adoption.

Dosage and administration

Adults and children over 12 years of age: one tablet twice a day, every 12 hours. Children 6 to 12 years of age: weighing more than 30 kg: one teaspoon (5 ml) twice a day, every 12 hours. Children 4 to 6 years of age: weighing 30 kg or less: half (½) teaspoon (2.5 ml) twice a day, every 12 hours. The dosage should be determined individually and adjusted according to the specific disease, its severity and the clinical response. When improvement is observed, the dosage should be gradually reduced to a minimum level of maintenance and suspended whenever possible. When the symptoms of respiratory allergy have been adequately controlled, consideration should be given to gradually withdrawing the combined product and using antihistamine only.

Contraindications

Celestamine NS is contraindicated in patients with systemic fungal infections and in those with hypersensitivity to any of its components or to drugs of similar chemical structures, pregnancy and lactation.

Side effects

Celestamine NS has no clinically significant sedative effects at the recommended daily dose (10 mg).

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The most commonly reported adverse effects include fatigue, headache, drowsiness, dry mouth, gastrointestinal disorders such as nausea and gastritis, and allergic symptoms such as rashes.

Rarely, cases of alopecia, anaphylaxis, liver disorders have been reported.

Other reported adverse reactions include:

  • Fluid and electrolyte disorders: sodium retention, potassium loss, hypocalcemic alkalosis, fluid retention, congestive heart failure in sensitive patients, hypertension;
  • Osteomuscular: muscle weakness, corticosteroid myopathy, loss of muscle mass, worsening of myasthenic symptoms in myasthenia gravis, osteoporosis, vertebral fractures, compression, aseptic necrosis of the femoral and humeral heads, pathological fracture of the long bones, tendon rupture;
  • Gastrointestinal: peptic ulcer with the possibility of further perforation and bleeding, pancreatitis, abdominal distension, ulcerative esophagitis;
  • Dermatological: impairment of wound healing, skin atrophy, fragile and thin skin, petechiae and ecchymosis, facial erythema, increased sweating, suppression of reactions such as allergic dermatitis, urticaria, angioneurotic edema;
  • Neurological: seizures, increased intracranial pressure with papilledema (cerebral pseudotumor), vertigo, headache;
  • Endocrine: menstrual irregularities, cushingoid status, suppression of intrauterine fetal or childhood growth, lack of secondary response of the adrenal cortex or pituitary, particularly in times of stress, such as trauma, surgery or state of disease, reduced carbohydrate tolerance, manifestations of latent diabetes mellitus, increased requirements for insulin or oral hypoglycemic agents in diabetic patients;
  • Ophthalmic: posterior subcapsular cataracts, increased intraocular pressure, glaucoma, exophthalmos;
  • Metabolic: negative nitrogen balance due to protein catabolism;
  • Psychiatric: euphoria, violent mood changes, from severe depression to frankly psychotic manifestations, personality changes, exaggerated irritability, insomnia;
  • Others: anaphylactoid and hypersensitivity reactions and hypotensive or shock-like reactions.

Overdose

Celestamine NS is a combined product, so the potential toxicity of each of its components must be considered.

An overdose can cause the following adverse reactions: drowsiness, tachycardia and headache. A single intake of 160 mg of loratadine produced no adverse effects. If necessary, the treatment should be started immediately (symptomatic and adjuvant). It is not expected that a single excessive dose of betamethasone will cause acute symptoms. Except for the most extreme dosages, it is unlikely that a few days of excessive glucocorticoid administration will cause harmful results, except in patients at special risk due to primary conditions or who are receiving concomitant medication that is likely to interact adversely with betamethasone. Treatment: vomiting should be induced even if emesis has occurred spontaneously. Pharmacologically induced vomiting by the administration of syrup of ipecac is the preferred method. However, vomiting should not be induced in patients with altered awake state. The action of ipecac is facilitated by physical activity and by the administration of 240 to 360 milliliters of water. If emesis does not occur within 15 minutes of administering ipecac, the dose should be repeated. Precautions should be taken to avoid bronchoaspiration, especially in children. After emesis, try to absorb any remaining medication in the stomach by administering activated carbon as a thick suspension in water. If vomiting cannot be induced or is contraindicated, gastric lavage should be performed. The physiological saline solution is preferred for gastric lavage, especially in children. In adults, tap water can be used; however, before proceeding to the next instillation, the greatest possible volume of fluid previously administered should be removed. Saline cathartics attract water into the intestine by osmosis and, therefore, can be valuable because of their rapid diluting action of intestinal contents. Loratadine is not cleared by hemodialysis to any degree appreciable after administering emergency treatment, the patient should be kept under medical surveillance. The treatment of the signs and symptoms of overdose is symptomatic and supportive. Maintain adequate fluid intake and monitor serum and urinary electrolytes, paying particular attention to sodium and potassium balance. If necessary, treat electrolyte imbalance.

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Interaction

Loratadine: when administered concomitantly with alcohol, loratadine has no potentiating effects as measured by psychomotor performance studies. An increase in plasma concentrations of loratadine has been reported after concomitant administration of ketoconazole, erythromycin or cimetidine in controlled clinical studies, but no clinically significant changes (including electrocardiographic) have been observed. Caution should be exercised when other drugs that inhibit liver metabolism are co-administered until definitive interaction studies can be performed.

Betamethasone: the concomitant use of phenobarbital, rifampicin, diphenylidantohyne or ephedrine may increase corticosteroid metabolism by decreasing its therapeutic action. Patients who received a corticosteroid and an estrogen should be observed for the possible increase in corticosteroid effects. Simultaneous administration of corticosteroids with diuretics that cause increased potassium elimination could increase hypokalemia. Concomitant use of corticosteroids with cardiac glycosides may increase the possibility of arrhythmias or digital toxicity associated with hypokalemia. Corticosteroids can increase potassium depletion caused by amphotericin B. In all these patients, serum electrolyte determinations should be performed, particularly potassium levels should be carefully monitored. Concomitant use of corticosteroids with coumarin-type anticoagulants may increase or decrease the anticoagulant effects, possibly requiring dose adjustment. The combined effects of non-corticosteroid anti-inflammatory drugs or alcohol with corticosteroids could increase the incidence or increase the severity of gastrointestinal ulcers. Corticosteroids can reduce blood salicylate concentrations. Acetylsalicylic acid should be used carefully in conjunction with corticosteroids in case of hypoprothrombinemia. When corticosteroids are administered to diabetics, an adjustment of the antidiabetic drug may be required. Concomitant use of corticosteroids with somatropin may inhibit the response to somatropin.