Tolol AM Dosage

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Dosage of Tolol AM in details

The dose of a drug and dosage of the drug are two different terminologies. Dose is defined as the quantity or amount of medicine given by the doctor or taken by the patient at a given period. Dosage is the regimen prescribed by the doctor about how many days and how many times per day the drug is to be taken in specified dose by the patient. The dose is expressed in mg for tablets or gm, micro gm sometimes, ml for syrups or drops for kids syrups. The dose is not fixed for a drug for all conditions, and it changes according to the condition or a disease. It also changes on the age of the patient.
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Adults

The usual initial antihypertensive oral dose of Tolol AM is 5 mg once daily, and the maximum dose is 10 mg once daily.

Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Tolol AM to other antihypertensive therapy.

Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

Angina

The recommended dose for chronic stable or vasospastic angina is 5–10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.

Coronary Artery Disease

The recommended dose range for patients with coronary artery disease is 5–10 mg once daily. In clinical studies, the majority of patients required 10 mg.

Children

The effective antihypertensive oral dose in pediatric patients ages 6–17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients.

How supplied

Dosage Forms And Strengths

Tablets

2.5 mg white, diamond, flat-faced, beveled edged, with "Tolol AM" on one side and "2.5" on the other Tablets: 5 mg white, elongated octagon, flat-faced, beveled edged, with "Tolol AM" on one side and "5" on the other Tablets: 10 mg white, round, flat-faced, beveled edge, with "Tolol AM" on one side and "10" on the other

Storage And Handling

2.5 mg Tablets

Tolol AM – 2.5 mg Tablets (Tolol AM besylate equivalent to 2.5 mg of Tolol AM per tablet) are supplied as white, diamond, flat-faced, beveled edged engraved with "Tolol AM" on one side and "2.5" on the other side and supplied as follows:

NDC 0069-1520-68 Bottle of 90

5 mg Tablets

Tolol AM – 5 mg Tablets (Tolol AM besylate equivalent to 5 mg of Tolol AM per tablet) are white, elongated octagon, flat-faced, beveled edged engraved with both "Tolol AM" and "5" on one side and plain on the other side and supplied as follows:

NDC 0069-1530-68 Bottle of 90

NDC 0069-1530-41 Unit Dose package of 100

NDC 0069-1530-72 Bottle of 300

10 mg Tablets

Tolol AM – 10 mg Tablets (Tolol AM besylate equivalent to 10 mg of Tolol AM per tablet) are white, round, flat-faced, beveled edged engraved with both "Tolol AM" and "10" on one side and plain on the other side and supplied as follows:

NDC 0069-1540-68 Bottle of 90

NDC 0069-1540-41 Unit Dose package of 100

Storage

Store bottles at controlled room temperature, 59° to 86°F (15° to 30°C) and dispense in tight, lightresistant containers (USP).

Manufactured by: Pfizer, Pfizer Labs, Division of Pfizer Inc, NY, NY 10017. Revised: March 2015

What other drugs will affect Tolol AM?

Tell your doctor about all your other medicines, especially:

This list is not complete. Other drugs may affect Tolol AM, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Tolol AM drug interactions (in more detail)

Tolol AM interactions

Interactions are the effects that happen when the drug is taken along with the food or when taken with other medications. Suppose if you are taking a drug Tolol AM, it may have interactions with specific foods and specific medications. It will not interact with all foods and medications. The interactions vary from drug to drug. You need to be aware of interactions of the medicine you take. Most medications may interact with alcohol, tobacco, so be cautious.
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Tolol AM has been safely administered with thiazide diuretics, α-blockers, β-blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, nonsteroidal anti-inflammatory drugs, antibiotics and oral hypoglycemic drugs.

In vitro data from studies with human plasma indicate that Tolol AM has no effect on protein binding of the drugs tested (digoxin, phenytoin, warfarin, or indomethacin).

Simvastatin: Co-administration of multiple doses of 10 mg Tolol AM with 80 mg simvastatin resulted in a 77% increase in exposure to simvastatin compared to simvastatin alone. Limit the dose of simvastatin in patients on Tolol AM to 20 mg daily.

Grapefruit Juice: Co-administration of 240 mL grapefruit juice with a single oral dose of 10 mg Tolol AM in 20 healthy volunteers had no significant effect on the pharmacokinetics of Tolol AM. The study did not allow examination of the effect of genetic polymorphism in CYP3A4, the primary enzyme responsible for metabolism of Tolol AM; therefore, administration of Tolol AM with grapefruit or grapefruit juice is not recommended as bioavailability may be increased in some patients, resulting in increased blood pressure lowering effects.

CYP3A4 Inhibitors: Co-administration of a 180 mg daily dose of diltiazem with 5 mg Tolol AM in elderly hypertensive patients (69 to 87 years of age) resulted in a 57% increase in Tolol AM systemic exposure. Co-administration of erythromycin in healthy volunteers (18 to 43 years of age) did not significantly change Tolol AM systemic exposure [22% increase in area under the concentration versus time curve (AUC)]. Although the clinical relevance of these findings is uncertain, pharmacokinetic variations may be more pronounced in the elderly.

Strong inhibitors of CYP3A4 (e.g., ketoconazole, itraconazole, ritonavir) may increase the plasma concentrations of Tolol AM to a greater extent than diltiazem. Tolol AM should be used with caution when administered with CYP3A4 inhibitors.

Clarithromycin: Clarithromycin is an inhibitor of CYP3A4. There is an increased risk of hypotension in patients receiving clarithromycin with Tolol AM. Close observation of patients is recommended when Tolol AM is co-administered with clarithromycin.

CYP3A4 Inducers: There is no data available regarding the effect of CYP3A4 inducers on Tolol AM. Concomitant use of CYP3A4 inducers (e.g., rifampicin, hypericum perforatum) may decrease the plasma concentrations of Tolol AM. Tolol AM should be used with caution when administered with CYP3A4 inducers.

In the following studies, there were no significant changes in the pharmacokinetics of either Tolol AM or another drug within the study, when co-administered.

Special Studies: Effect of Other Agents on Tolol AM: Cimetidine: Co-administration of Tolol AM with cimetidine did not alter the pharmacokinetics of Tolol AM.

Aluminum/Magnesium (Antacid): Co-administration of aluminum/magnesium (antacid) with a single dose of Tolol AM had no significant effect on the pharmacokinetics of Tolol AM.

Sildenafil: A single 100 mg dose of sildenafil in subjects with essential hypertension had no effect on the pharmacokinetic parameters of Tolol AM. When Tolol AM and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect.

Effect of Tolol AM on Other Agents: Atorvastatin: Co-administration of multiple 10 mg doses of Tolol AM with 80 mg atorvastatin resulted in no significant change in the steady-state pharmacokinetic parameters of atorvastatin.

Digoxin: Co-administration of Tolol AM with digoxin did not change serum digoxin levels or digoxin renal clearance in healthy volunteers.

Ethanol (Alcohol): Single and multiple 10 mg doses of Tolol AM had no significant effect on the pharmacokinetics of ethanol.

Warfarin: Co-administration of Tolol AM with warfarin did not change the warfarin prothrombin response time.

Cyclosporin: No drug interaction studies have been conducted with cyclosporin and Tolol AM in healthy volunteers or other populations, with the exception of renal transplant patients. Various studies in renal transplant patients report that co-administration of Tolol AM with cyclosporin affects the trough concentrations of cyclosporin, from no change up to an average increase of 40%. Consideration should be given for monitoring cyclosporin levels in renal transplant patients on Tolol AM.

Tacrolimus: There is a risk of increased tacrolimus blood levels when co-administered with Tolol AM. In order to avoid toxicity of tacrolimus, administration of Tolol AM in a patient treated with tacrolimus requires monitoring of tacrolimus blood levels and dose adjustment of tacrolimus when appropriate.

Drug/Laboratory Test Interactions: None known.


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References

  1. DailyMed. "METOPROLOL FUMARATE: 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. MeSH. "Antihypertensive Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "3,5-Pyridinedicarboxylic acid, 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-, 3-ethyl 5-methyl ester: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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