Product image of Oroxine (Levothyroxine Sodium Pentahydrate) supplied by GNH India

Oroxine

Active Ingredient:
Levothyroxine Sodium Pentahydrate
Origin:
EU

Oroxine (Levothyroxine Sodium Pentahydrate)

Levothyroxine sodium pentahydrate, the active ingredient in Oroxine, is a thyroid hormone replacement presented as a tablet for oral use. It treats hypothyroidism by supplying the body with a synthetic form of the thyroid hormone thyroxine, helping to normalize metabolic processes in patients with thyroid hormone deficiency.

GNH India supplies Oroxine as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Aspen Pharma Trading Limited

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Indications & Clinical Uses

Oroxine (levothyroxine) is used within the endocrine therapeutic area to restore normal thyroid hormone levels.

  • Primary hypothyroidism: normalizes thyroid hormone concentrations and alleviates symptoms such as fatigue and weight gain.
  • Secondary (central) hypothyroidism: provides needed hormone replacement when the pituitary gland fails to stimulate the thyroid.
  • Congenital hypothyroidism: ensures adequate thyroid hormone for growth and neurodevelopment in affected infants.

How It Works

  • Levothyroxine sodium pentahydrate is a synthetic analogue of the endogenous thyroid hormone thyroxine (T4). After oral absorption, it is converted to the active hormone triiodothyronine (T3) in peripheral tissues, where it binds to nuclear thyroid hormone receptors, modulating gene transcription and regulating basal metabolic rate, protein synthesis, and growth.

Side Effects

Adverse reactions to levothyroxine are generally dose‑related and may affect multiple organ systems.

Common Side Effects

  • Palpitations: sensation of rapid or irregular heartbeat.
  • Nervousness or anxiety: heightened nervous system activity.
  • Tremor: fine shaking of the hands.
  • Heat intolerance: increased sensitivity to warm environments.
  • Weight loss: unintended reduction in body weight.
  • Menstrual irregularities: changes in cycle timing or flow.

Serious or Rare Side Effects

  • Cardiac arrhythmias: potentially life‑threatening rhythm disturbances.
  • Osteoporosis: decreased bone mineral density with long‑term overtreatment.
  • Acute allergic reactions: rash, itching, or swelling.
  • Hyperthyroid crisis (thyrotoxicosis): severe over‑replacement symptoms requiring urgent care.

Precautions & Warnings

Levothyroxine requires careful monitoring and individualized dosing to avoid over‑ or under‑replacement.

  • Baseline assessment: obtain thyroid function tests before initiating therapy.
  • Dose adjustments: modify based on periodic TSH and free T4 measurements.
  • Drug interactions: review concomitant medications that may alter absorption or metabolism.
  • Pregnancy and lactation: monitor thyroid status closely, as requirements may change.
  • Cardiovascular disease: start with low doses and titrate cautiously.
  • Store at ambient temperature: keep tablets in the original container, protect from moisture and direct sunlight.

Avoid Interactions

Levothyroxine may have clinically significant interactions with several drug classes.

Major Interactions (Avoid)

  • Antacids containing aluminum or magnesium: reduce levothyroxine absorption; separate dosing by at least 4 hours.
  • Iron supplements: markedly decrease absorption; separate dosing by at least 4 hours.
  • Corticosteroids (high dose): may increase levothyroxine clearance, necessitating dose adjustment.

Moderate Interactions (Monitor Closely)

  • Cholesterol‑lowering agents (e.g., cholestyramine, colestipol): may modestly reduce absorption.
  • Antidepressants (SSRIs, tricyclics): can affect thyroid hormone levels.
  • Oral contraceptives and hormone replacement therapy: may increase levothyroxine requirements.

Frequently Asked Questions

Oroxine contains levothyroxine sodium pentahydrate, a synthetic thyroid hormone used to replace deficient thyroxine in patients with hypothyroidism, helping to restore normal metabolism and alleviate related symptoms.

Levothyroxine is absorbed from the gut and converted to the active hormone triiodothyronine (T3) in peripheral tissues. It then binds to nuclear thyroid hormone receptors, regulating gene expression that controls metabolism, growth, and development.

The dose of Oroxine is individualized; a prescriber determines the appropriate amount based on the patient’s age, weight, thyroid function tests, and clinical response.

Levothyroxine is generally considered safe in pregnancy and lactation when medically indicated, but thyroid function should be closely monitored and dose adjustments made as needed to maintain euthyroid status.

To order, submit an enquiry on the Oroxine product page at gnhindia.com, providing the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then replies with pricing, availability, shipping details and any necessary import documentation.

Oroxine’s active ingredient, levothyroxine, is the standard of care for thyroid hormone replacement and is comparable to other levothyroxine brands in efficacy. Alternatives such as liothyronine (T3) provide a more rapid onset but are less commonly used due to a shorter half‑life.

Store Oroxine tablets at ambient temperature, below 25 °C, in the original packaging. Protect them from moisture, heat and direct sunlight to maintain potency.

Oroxine is taken orally, usually once daily on an empty stomach, preferably 30‑60 minutes before breakfast, with a full glass of water to ensure consistent absorption.

Serious risks include cardiac arrhythmias, osteoporosis from long‑term overtreatment, and rare cases of severe allergic reactions. Patients should be monitored regularly for signs of over‑ or under‑replacement.

Oroxine is contraindicated in patients with untreated adrenal insufficiency, acute myocardial infarction, or known hypersensitivity to levothyroxine or any tablet excipients.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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