Timolol 0.25% FDC Dosage

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Dosage of Timolol 0.25% FDC in details

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Hypertension

The usual initial dosage of Timolol 0.25% FDC (Timolol 0.25% FDC) is 10 mg twice a day, whether used alone or added to diuretic therapy. Dosage may be increased or decreased depending on heart rate and blood pressure response. The usual total maintenance dosage is 20-40 mg per day. Increases in dosage to a maximum of 60 mg per day divided into two doses may be necessary. There should be an interval of at least seven days between increases in dosages.

Timolol 0.25% FDC (Timolol 0.25% FDC) may be used with a thiazide diuretic or with other antihypertensive agents. Patients should be observed carefully during initiation of such concomitant therapy.

Myocardial Infarction

The recommended dosage for long-term prophylactic use in patients who have survived the acute phase of a myocardial infarction is 10 mg given twice daily.

Migraine

The usual initial dosage of Timolol 0.25% FDC (Timolol 0.25% FDC) is 10 mg twice a day. During maintenance therapy the 20 mg daily dosage may be administered as a single dose. Total daily dosage may be increased to a maximum of 30 mg, given in divided doses, or decreased to 10 mg once per day, depending on clinical response and tolerability. If a satisfactory response is not obtained after 6-8 weeks use of the maximum daily dosage, therapy with Timolol 0.25% FDC (Timolol 0.25% FDC) should be discontinued.

How supplied

No. 3343 — Tablets Timolol 0.25% FDC (Timolol 0.25% FDC), 5 mg, are light blue, round, compressed tablets, with code MSD 59 on one side and Timolol 0.25% FDC (Timolol 0.25% FDC) on the other. They are supplied as follows:

NDC 0006-0059-68 bottles of 100.

No. 3344 — Tablets Timolol 0.25% FDC (Timolol 0.25% FDC), 10 mg, are light blue, round, scored, compressed tablets, with code MSD 136 on one side and Timolol 0.25% FDC (Timolol 0.25% FDC) on the other. They are supplied as follows:

NDC 0006-0136-68 bottles of 100

No. 3371 — Tablets Timolol 0.25% FDC (Timolol 0.25% FDC), 20 mg, are light blue, capsule shaped, scored, compressed tablets, with code MSD 437 on one side and Timolol 0.25% FDC (Timolol 0.25% FDC) on the other. They are supplied as follows:

NDC 0006-0437-68 bottles of 100

Storage

Store at controlled room temperature, 15-30°C (59-86°F). Keep container tightly closed. Protect from light.

MERCK AND CO., INC., Whitehouse Station, NJ 08889, USA. Issued April 2001. FDA Rev date: 2/25/2003

What other drugs will affect Timolol 0.25% FDC?

Before taking Timolol 0.25% FDC, tell your doctor if you are using:

If you are using any of these drugs, you may not be able to take Timolol 0.25% FDC, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Timolol 0.25% FDC. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Timolol 0.25% FDC interactions

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Beta-adrenergic blocking agents: Patients who are receiving a beta-adrenergic blocking agent orally and Phoxal-Timolol 0.25% FDC GFS should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. Patients should not usually receive two topical ophthalmic beta-adrenergic blocking agents concurrently.

Calcium antagonists: Caution should be used in the co-administration of beta-adrenergic blocking agents, such as Phoxal-Timolol 0.25% FDC GFS, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, or hypotension. In patients with impaired cardiac function, co-administration should be avoided.

ENDOCRINE

Masked symptoms of hypoglycemia in diabetic patients. SPECIAL SENSES

Signs and symptoms of ocular irritation including blepharitis, keratitis, and dry eyes; ptosis; decreased corneal sensitivity; cystoid macular edema; visual disturbances including refractive changes and diplopia; pseudopemphigoid; tinnitus and choroidal detachment following filtration surgery.

UROGENITAL

Retroperitoneal fibrosis, decreased libido, impotence and Peyronieís disease.

The following additional adverse effects have been reported in clinical experience with ORAL Timolol 0.25% FDC maleate or other ORAL beta-blocking agents and may be considered potential effects of ophthalmic Timolol 0.25% FDC maleate: Allergic: Erythematous rash, fever combined with aching and sore throat, laryngospasm with respiratory distress; Body as a Whole: Extremity pain, decreased exercise tolerance, weight loss; Cardiovascular: Worsening of arterial insufficiency, vasodilatation; Digestive: Gastrointestinal pain, hepatomegaly, vomiting, mesenteric arterial thrombosis, ischemic colitis; Hematologic: Nonthrombocytopenic purpura, thrombocytopenic purpura, agranulocytosis; Endocrine: Hyperglycemia, hypoglycemia; Skin: Pruritus, skin irritation, increased pigmentation, sweating; Musculoskeletal: Arthralgia; Nervous System/Psychiatric: Vertigo, local weakness, diminished concentration, reversible mental depression progressing to catatonia, an acute reversible syndrome characterized by disorientation for time and place, emotional lability, slightly clouded sensorium, and decreased performance on neuropsychometric tests; Respiratory: Rales, bronchial obstruction; Urogenital: Urination difficulties.


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References

  1. DailyMed. "TIMOLOL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. FDA/SPL Indexing Data. "5JKY92S7BR: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
  3. MeSH. "Antihypertensive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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