Mustafa Nevzat Pharmaceuticals
Prednol tb
Prednol
  • Prednol tablet 4-16 mg, 20 tablets

Composition

Each tablet contains 4-16 mg methylprednisolone.

Features

  • A non-fluorinated synthetic corticosteroid.
  • More potent antiinflammatory effect compared to hydrocortisone and prednisolone.
  • Minimum mineralocorticoid activity.
  • A corticosteroid with intermediate duration of action ideal for alternate-day therapy.

Indications

  • Endocrine disorders
  • Rheumatic and collagen tissue disorders
  • Respiratory tract disorders
  • Severe infections
  • Neoplastic disorders
  • Nephrotic syndrome
  • Allergic disorders
  • Dermatologic disorders
  • Ophtalmic disorders

Contraindications

Methylprednisolone is contraindicated in patients with systemic fungal infections and known hypersensitivity to methylprednisolone.

Warnings and Precautions

In patients on corticosteroid therapy subjected to any unusual stress, increased dosage of rapidly acting corticosteroids before, during and after the stressful situation is indicated. Corticosteroids may mask some signs of infections, and new infections may appear during their use. Prolonged use of corticosteroids may produce posterior sub capsular cataracts and glaucoma with possible damage to the optic nerves and may also enhance the establishment of secondary ocular infections due to fungi or viruses.Because rare instances of anaphylactic reactions have occurred in patients receiving parenteral corticosteroid therapy, appropriate precautionary measures should be taken prior to administration, especially when the patient has a history of allergy to any drug. Steroids should be used with caution in nonspecific ulcerative colitis, diverticulitis, fresh intestinal anastomoses, active or latent peptic ulcer; renal insufficiency; hypertension; osteoporosis and myasthenia gravis. Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunossuppressive doses of corticosteroids; killed or inactivated vaccines may be administered to patients receiving immunosuppresive doses of corticosteroids. If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary as reactivation of the disease may occur. Safety of administration during pregnancy has not been established. Infants born to mothers who had to receive substantial doses of corticosteroids during pregnancy should be carefully observed for signs of hypoadrenalism. During prolonged therapies, growth and development of infants and children should be closely observed.

Adverse Reactions

Although the side effects observed during methylprednisolone therapy are milder than those seen with other corticosteroids, they follow the same pattern. Side effects such as peptic ulcer, decreases in resistance to infections, development of osteoporosis, psychic disturbances, hirsutism, amenorrhea and acne purpura that are observed with glucocorticoid treatment can also be seen after methylprednisolone therapy but they are milder.

Drug Interactions

Since drugs that stimulate enzyme secretion such as rifampin, phenobarbital and phenytoin increase the hepatic binding and biliary excretion of corticosteroids, they decrease the active methylprednisolone levels; response to anticoagulants can be decreased. Salicylate metabolism is accelerated, especially in males.

Dosage and Administration


DISEASES INITIAL DAILY DOSE
ENDOCRINE DISORDERS Adrenocortical insufficiency 20 mg (every 6 hours)
Congenital adrenal hyperplasia 4 - 16 mg
Non-suppurative thyroiditis 16-24 mg
RHEUMATIC AND COLLAGEN TISSUE DISORDERS
Arthritis and osteoarthritis 8 -16 mg
Acute rheumatic fever 32 - 80 mg
Acute rheumatic fever with carditis 1 mg/kg
Ankylosing spondylitis 8 - 16 mg
Acute and non-acute bursitis 16 - 24 mg
Acute nonspecific tenosynovitis 16 - 32 mg
Polymyositis 32 - 48 mg
Acute gouty arthritis 16 - 48 mg
Temporal arthritis 32 - 80 mg
Poly arthritis 32 - 96 mg
Systemic lupus erythematosus 64 - 200 mg
RESPIRATORY TRACT DISORDERS
Symptomatic sarcoidosis 32 - 48 mg
Loeffler syndrome 32 - 48 mg
Aspiration pneumonia 8 - 24 mg
Acute and disseminated tuberculosis 48 - 96 mg
SEVERE INFECTIONS 32 - 80 mg
NEOPLASTIC DISORDERS
Leukemia and lymphomas 16 - 96 mg
NEPHROTIC SYNDROME 64 - 80 mg
ALLERGIC DISORDERS
Bronchial asthma 16 - 48 mg
Allergic rhinitis 16 - 48 mg
Serum sickness 16 - 48 mg
Drug allergies 80 - 200 mg
Urticaria 32 - 48 mg
Contact dermatitis 16 - 48 mg
Atopic dermatitis 16 - 48 mg
Angio edema 32 - 48 mg
DERMATOLOGIC DISORDERS
Pemphigus 80 - 200 mg
Bullous dermatitis herpatiformis 48 - 96 mg
Erythema multiforme 64 - 80 mg
Exfoliative dermatitis 64 - 80 mg
Mycosis fungoides 48 - 96 mg
Severe psoriasis 8 - 16 mg
Severe seborrheic dermatitis 64 - 80 mg
OPHTALMIC DISORDERS
Allergic corneal ulcer 16 - 48 mg
Herpes zoster ophtalmicus 16 - 48 mg
Anterior segment inflammation 16 - 48 mg
Uveitis and chorioditis 16 - 48 mg
Sympathetic ophtalmia 16 - 48 mg
Allergic conjunctivitis 16 - 48 mg
Keratitis 16 - 48 mg
Chorio - retinitis 16 - 48 mg
Optic neuritis 16 - 48 mg
lritis and iridocyclitis 16 - 48 mg

Overdosage

In chronic overdosage, the probability of adrenal suppression should be considered. Symptomatic and supportive therapy should be administered. Methylprednisolone can be dialyzed.

Storage Conditions

Should be kept out of reach of children, at room temperature (< 25ºC) and in its package.

Available Forms

PREDNOL tablet 4 mg, 20-tablet blister packs

PREDNOL tablet 16 mg, 20-tablet blister packs

Name And Address Of The Authorisation Holder

Mustafa Nevzat Ilac Sanayii A.Þ. Prof. Dr. Bülent Tarcan Sok., Pak Iþ Merkezi No: 5/1 34349 Gayrettepe/Istanbul.

Name And Address Of The Manufacturing Company

Mustafa Nevzat Ilac Sanayii A.Þ. ÇobançeþmeMah.Sanayi Cad. No.13 Yenibosna-Istanbul.

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