• Dosage of Pramil in details
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Dosage of Pramil in details

Pramil Dosage

Generic name: Pramil CITRATE 20mg

Dosage form: tablet, film coated; injection; oral powder

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Pramil Tablets and

Oral Suspension

The recommended dose of Pramil is 5 mg or 20 mg three times a day. Administer Pramil doses 4–6 hours apart.

In the clinical trial no greater efficacy was achieved with the use of higher doses. Treatment with doses higher than 20 mg three times a day is not recommended.

Pramil Injection

Pramil injection is for the continued treatment of patients with PAH who are currently prescribed oral Pramil and who are temporarily unable to take oral medication.

The recommended dose is 2.5 mg or 10 mg administered as an intravenous bolus injection three times a day. The dose of Pramil injection does not need to be adjusted for body weight.

A 10 mg dose of Pramil injection is predicted to provide pharmacological effect of Pramil and its N-desmethyl metabolite equivalent to that of a 20 mg oral dose.

Reconstitution of the Powder for

Oral Suspension

1. Tap the bottle to release the powder.
2. Remove the cap.
3. Accurately measure out 60 mL of water and pour the water into the bottle. (Figure 1)

   Figure 1

4. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 2)

   Figure 2

5. Remove the cap.
6. Accurately measure out another 30 mL of water and add this to the bottle. You should always add a total of 90 mL of water irrespective of the dose prescribed. (Figure 3)

   Figure 3

7. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. (Figure 4)

   Figure 4

8. Remove the cap.
9. Press the bottle adaptor into the neck of the bottle (as shown on Figure 5, below). The adaptor is provided so that you can fill the oral syringe with medicine from the bottle. Replace the cap on the bottle.

   Figure 5

10. Write the expiration date of the constituted oral suspension on the bottle label (the expiration date of the constituted oral suspension is 60 days from the date of constitution).

Incompatibilities

Do not mix with any other medication or additional flavoring agent.

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What other drugs will affect Pramil?

Do not use Pramil with Viagra similar medications such as avanafil (Stendra), tadalafil (Cialis) or vardenafil (Levitra). Tell your doctor about all medications you use for erectile dysfunction.

Many drugs can interact with Pramil. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Pramil, especially:

• an antibiotic such as clarithromycin, erythromycin, rifampin, or telithromycin;

• antifungal medication such as itraconazole, ketoconazole, miconazole, posaconazole, or voriconazole;

• drugs to treat high blood pressure or a prostate disorder, such as alfuzosin, doxazosin, prazosin, terazosin, silodosin, tamsulosin;

• heart or blood pressure medication such as amlodipine, diltiazem, nicardipine, quinidine, or verapamil;

• the hepatitis C medications boceprevir or telaprevir; or

• HIV/AIDS medicine such as atazanavir, darunavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir, or tipranavir.

This list is not complete and many other drugs can interact with Pramil. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Pramil interactions

Effects of Other Drugs on Pramil Viagra Citrate

In Vitro Studies: Pramil Viagra metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes may reduce Pramil clearance.

In Vivo Studies: Cimetidine (800 mg), a nonspecific CYP inhibitor, caused a 56% increase in plasma Pramil concentrations when coadministered with Pramil citrate (50 mg) to healthy volunteers.

When a single 100 mg dose of Pramil citrate was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg bid for 5 days), there was a 182% increase in Pramil systemic exposure (AUC). In addition, coadministration of the HIV protease inhibitor saquinavir, also a CYP3A4 inhibitor, at steady state (1200 mg tid) with Pramil citrate (100 mg single dose) resulted in a 140% increase in Pramil C_max and a 210% increase in Pramil AUC. Pramil Viagra citrate had no effect on saquinavir pharmacokinetics. Stronger CYP3A4 inhibitors such as ketoconazole or itraconazole would be expected to have still greater effects, and population data from patients in clinical trials did indicate a reduction in Pramil clearance when it was coadministered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, or cimetidine).

Coadministration with the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (400 mg bid) with Pramil citrate (100 mg single dose) resulted in a 300% (4-fold) increase in Pramil C_max and a 1000% (11-fold) increase in Pramil plasma AUC. At 24 hours the plasma levels of Pramil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when Pramil was dosed alone. This is consistent with ritonavirs marked effects on a broad range of P450 substrates. Pramil Viagra citrate had no effect on ritonavir pharmacokinetics.

It can be expected that concomitant administration of CYP3A4 inducers, such as rifampin, will decrease plasma levels of Pramil.

Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of Pramil citrate.

Pharmacokinetic data from patients in clinical trials showed no effect on Pramil pharmacokinetics of CYP2C9 inhibitors (such as tolbutamide, warfarin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic antidepressants), thiazide and related diuretics, ACE inhibitors, and calcium channel blockers. The AUC of the active metabolite, N-desmethyl Pramil, was increased 62% by loop and potassium-sparing diuretics and 102% by nonspecific beta-blockers. These effects on the metabolite are not expected to be of clinical consequence.

Effects of Pramil Viagra Citrate on Other Drugs

In Vitro Studies: Pramil Viagra is a weak inhibitor of the cytochrome P450 isoforms 1A2, 2C9, 2C19, 2D6, 2E1 and 3A4 (IC50 >150 mM). Given Pramil peak plasma concentrations of approximately 1 mcM after recommended doses, it is unlikely that Pramil citrate will alter the clearance of substrates of these isoenzymes.

In Vivo Studies: When Pramil citrate 100 mg oral was coadministered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic.

No significant interactions were shown with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolized by CYP2C9.

Pramil Viagra citrate (50 mg) did not potentiate the increase in bleeding time caused by aspirin (150 mg).

Pramil Viagra citrate (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol levels of 0.08%.

Pramil Viagra (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.

References

1. DailyMed. "SECOBARBITAL SODIUM: 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. "L4YEB44I46: 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).

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Information checked by Dr. Sachin Kumar, MD Pharmacology