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Phentermine Resin

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Overview

What is Phentermine Resin?

Phentermine Resin Extended-Release Capsules contain 15 mg and 30 mg respectively of phentermine as the cationic exchange resin complex. Phentermine is α, α-dimethyl phenethylamine (phenyl-tertiarybutylamine).

Inactive Ingredients: dibasic calcium phosphate, talc, and magnesium stearate. The 15 mg capsule shell consists of D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide, gelatin, FD&C Blue No. 1, FD&C Red No. 40, FDA /E172 black iron oxide. The capsule imprinting ink consists of shellac glaze in ethanol, black iron oxide, N-butyl alcohol, propylene glycol, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, ethanol and methanol. The 30 mg capsule shell consists of D&C Yellow No. 10, FD&C Yellow No. 6, titanium dioxide, and gelatin. The capsule imprinting ink consists of shellac glaze in ethanol, black iron oxide, N-butyl alcohol, propylene glycol, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, D&C Yellow No. 10 Aluminum Lake, ethanol and methanol.



What does Phentermine Resin look like?



What are the available doses of Phentermine Resin?

Phentermine Resin Extended-Release Capsules are available in two strengths:

15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with “LCI” on the cap and “1398” on the body.

30 mg: Size #3 maize/maize capsules, imprinted with “LCI” on the cap and “1366” on the body.

What should I talk to my health care provider before I take Phentermine Resin?

How should I use Phentermine Resin?

Phentermine resin extended-release capsules are indicated as a short-term (a few weeks) adjunct in a regimen of weight reduction based on exercise, behavioral modification and caloric restriction in the management of exogenous obesity for patients with an initial body mass index ≥ 30 kg/m, or ≥ 27 kg/m in the presence of other risk factors (e.g., controlled hypertension, diabetes, hyperlipidemia).

Below is a chart of body mass index (BMI) based on various heights and weights.

BMI is calculated by taking the patient’s weight, in kilograms (kg), divided by the patient’s height, in meters (m), squared. Metric conversions are as follows: pounds ÷ 2.2 = kg; inches x 0.0254 = meters.

The limited usefulness of agents of this class, including phentermine, [see ] should be measured against possible risk factors inherent in their use such as those described below.

One capsule daily, before breakfast or 10-14 hours before retiring. For individuals exhibiting greater drug responsiveness, phentermine resin extended-release capsules, 15 mg, will usually suffice. Phentermine resin extended-release capsules, 30 mg, are recommended for less responsive patients. Phentermine resin extended-release capsules are not recommended for use in pediatric patients under 16 years of age.

Phentermine resin extended-release capsules should be swallowed whole.

Late evening medication should be avoided because of the possibility of resulting insomnia.


What interacts with Phentermine Resin?

Sorry No Records found


What are the warnings of Phentermine Resin?

Sorry No Records found


What are the precautions of Phentermine Resin?

Sorry No Records found


What are the side effects of Phentermine Resin?

Sorry No records found


What should I look out for while using Phentermine Resin?

History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) ()

During or within 14 days following the administration of monoamine oxidase inhibitors ()

Hyperthyroidism ()

Glaucoma ()

Agitated states ()

History of drug abuse ()

Pregnancy (, )

Nursing (, )

Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines ()


What might happen if I take too much Phentermine Resin?

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.


How should I store and handle Phentermine Resin?

Store between 20°C and 25°C (68°F and 77°F) Excursions permitted between 15°C and 30°C (59°F and 86°F).Protect from light.Store between 20°C and 25°C (68°F and 77°F) Excursions permitted between 15°C and 30°C (59°F and 86°F).Protect from light.Phentermine Resin Extended-Release Capsules are available in two strengths:15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with “LCI” on the cap and “1398” on the body, in bottles of 100 capsules (NDC 0527-1398-01).30 mg: Size #3 maize/maize capsules, imprinted with “LCI” on the cap and “1366” on the body, in bottles of 100 capsules (NDC 0527-1366-01).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, well-closed container as defined in the USP, with a child-resistant closure (as required).Keep out of the reach of children.Phentermine Resin Extended-Release Capsules are available in two strengths:15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with “LCI” on the cap and “1398” on the body, in bottles of 100 capsules (NDC 0527-1398-01).30 mg: Size #3 maize/maize capsules, imprinted with “LCI” on the cap and “1366” on the body, in bottles of 100 capsules (NDC 0527-1366-01).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, well-closed container as defined in the USP, with a child-resistant closure (as required).Keep out of the reach of children.Phentermine Resin Extended-Release Capsules are available in two strengths:15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with “LCI” on the cap and “1398” on the body, in bottles of 100 capsules (NDC 0527-1398-01).30 mg: Size #3 maize/maize capsules, imprinted with “LCI” on the cap and “1366” on the body, in bottles of 100 capsules (NDC 0527-1366-01).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, well-closed container as defined in the USP, with a child-resistant closure (as required).Keep out of the reach of children.Phentermine Resin Extended-Release Capsules are available in two strengths:15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with “LCI” on the cap and “1398” on the body, in bottles of 100 capsules (NDC 0527-1398-01).30 mg: Size #3 maize/maize capsules, imprinted with “LCI” on the cap and “1366” on the body, in bottles of 100 capsules (NDC 0527-1366-01).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, well-closed container as defined in the USP, with a child-resistant closure (as required).Keep out of the reach of children.Phentermine Resin Extended-Release Capsules are available in two strengths:15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with “LCI” on the cap and “1398” on the body, in bottles of 100 capsules (NDC 0527-1398-01).30 mg: Size #3 maize/maize capsules, imprinted with “LCI” on the cap and “1366” on the body, in bottles of 100 capsules (NDC 0527-1366-01).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, well-closed container as defined in the USP, with a child-resistant closure (as required).Keep out of the reach of children.Phentermine Resin Extended-Release Capsules are available in two strengths:15 mg: Size #3 grey opaque/maize opaque capsules, imprinted with “LCI” on the cap and “1398” on the body, in bottles of 100 capsules (NDC 0527-1398-01).30 mg: Size #3 maize/maize capsules, imprinted with “LCI” on the cap and “1366” on the body, in bottles of 100 capsules (NDC 0527-1366-01).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].Dispense in a tight, well-closed container as defined in the USP, with a child-resistant closure (as required).Keep out of the reach of children.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Phentermine is a sympathomimetic amine with pharmacologic activity similar to the prototype drugs of this class used in obesity, amphetamine (d- and d/l-amphetamine). Drugs of this class used in obesity are commonly known as "anorectics" or "anorexigenics." It has not been established that the primary action of such drugs in treating obesity is one of appetite suppression since other central nervous system actions, or metabolic effects, may also be involved.

Non-Clinical Toxicology
History of cardiovascular disease (e.g., coronary artery disease, stroke, arrhythmias, congestive heart failure, uncontrolled hypertension) ()

During or within 14 days following the administration of monoamine oxidase inhibitors ()

Hyperthyroidism ()

Glaucoma ()

Agitated states ()

History of drug abuse ()

Pregnancy (, )

Nursing (, )

Known hypersensitivity, or idiosyncrasy to the sympathomimetic amines ()

Psychotropic Agents:





The use of monoamine oxidase inhibitors (MAOIs) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. The use of buspirone within 14 days of stopping an MAOI intended to treat depression is also contraindicated.

Starting buspirone in a patient who is being treated with reversible MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see , and )





After addition of buspirone to the amitriptyline dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C , AUC, and C ) of amitriptyline or its metabolite nortriptyline were observed.





After addition of buspirone to the diazepam dose regimen, no statistically significant differences in the steady-state pharmacokinetic parameters (C , AUC, and C ) were observed for diazepam, but increases of about 15% were seen for nordiazepam, and minor adverse clinical effects (dizziness, headache, and nausea) were observed.





In a study in normal volunteers, concomitant administration of buspirone and haloperidol resulted in increased serum haloperidol concentrations. The clinical significance of this finding is not clear.





[see ].





There is one report suggesting that the concomitant use of Desyrel (trazodone hydrochloride) and buspirone may have caused 3- to 6-fold elevations on SGPT (ALT) in a few patients. In a similar study attempting to replicate this finding, no interactive effect on hepatic transaminases was identified.





Coadministration of buspirone with either triazolam or flurazepam did not appear to prolong or intensify the sedative effects of either benzodiazepine.

Other Psychotropics:

Because the effects of concomitant administration of buspirone with most other psychotropic drugs have not been studied, the concomitant use of buspirone with other CNS-active drugs should be approached with caution.





Buspirone has been shown to be metabolized by CYP3A4.  This finding is consistent with the interactions observed between buspirone and the following:





In a study of nine healthy volunteers, coadministration of buspirone (10 mg as a single dose) with verapamil (80 mg t.i.d.) or diltiazem (60 mg t.i.d.) increased plasma buspirone concentrations (verapamil increased AUC and C of buspirone 3.4-fold while diltiazem increased AUC and C 5.5-fold and 4-fold, respectively.)  Adverse events attributable to buspirone may be more likely during concomitant administration with either diltiazem or verapamil.  Subsequent dose adjustment may be necessary and should be based on clinical assessment.





In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with erythromycin (1.5 g/day for 4 days) increased plasma buspirone concentrations     (5-fold increase in C and 6-fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone.  If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg b.i.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.





In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with grapefruit juice (200 mL double-strength t.i.d. for 2 days) increased plasma buspirone concentrations (4.3-fold increase in C ; 9.2-fold increase in AUC). Patients receiving buspirone should be advised to avoid drinking such large amounts of grapefruit juice.





In a study in healthy volunteers, coadministration of buspirone (10 mg as a single dose) with itraconazole (200 mg/day for 4 days) increased plasma buspirone concentrations (13-fold increase in C and 19-fold increase in AUC). These pharmacokinetic interactions were accompanied by an increased incidence of side effects attributable to buspirone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.





In a study of steady-state pharmacokinetics in healthy volunteers, coadministration of buspirone (2.5 or 5 mg b.i.d.) with nefazodone (250 mg b.i.d.) resulted in marked increases in plasma buspirone concentrations (increases up to 20-fold in C and up to 50-fold in AUC) and statistically significant decreases (about 50%) in plasma concentrations of the buspirone metabolite 1-PP. With 5 mg b.i.d. doses of buspirone, slight increases in AUC were observed for nefazodone (23%) and its metabolites hydroxynefazodone (HO-NEF) (17%) and meta-chlorophenylpiperazine (9%). Slight increases in C were observed for nefazodone (8%) and its metabolite HO-NEF (11%).

Subjects receiving buspirone 5 mg b.i.d. and nefazodone 250 mg b.i.d experienced lightheadedness, asthenia, dizziness, and somnolence, adverse events also observed with either drug alone. If the two drugs are to be used in combination, a low dose of buspirone (e.g., 2.5 mg q.d.) is recommended. Subsequent dose adjustment of either drug should be based on clinical assessment.





In a study in healthy volunteers, coadministration of buspirone (30 mg as a single dose) with rifampin (600 mg/day for 5 days) decreased the plasma concentrations (83.7% decrease in C ; 89.6% decrease in AUC) and pharmacodynamic effects of buspirone.  If the two drugs are to be used in combination, the dosage of buspirone may need adjusting to maintain anxiolytic effect.

Other Inhibitors and Inducers of CYP3A4:

Substances that inhibit CYP3A4, such as ketoconazole or ritonavir, may inhibit buspirone metabolism and increase plasma concentrations of buspirone while substances that induce CYP3A4, such as dexamethasone, or certain anticonvulsants (phenytoin, phenobarbital, carbamazepine), may increase the rate of buspirone metabolism.  If a patient has been titrated to a stable dosage on buspirone, a dose adjustment of buspirone may be necessary to avoid adverse events attributable to buspirone or diminished anxiolytic activity. Consequently, when administered with a potent inhibitor of CYP3A4, a low dose of buspirone used cautiously is recommended.  When used in combination with a potent inducer of CYP3A4 the dosage of buspirone may need adjusting to maintain anxiolytic effect.

Other Drugs:





Coadministration of buspirone with cimetidine was found to increase C (40%) and T (2–fold), but had minimal effects on the AUC of buspirone.

Protein Binding:





Therapeutic levels of aspirin, desipramine, diazepam, flurazepam, ibuprofen, propranolol, thioridazine, and tolbutamide had only a limited effect on the extent of binding of buspirone to plasma proteins (see ).

Phentermine resin extended-release capsules are indicated only as short-term (a few weeks) monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss including prescribed drugs, over-the-counter preparations, and herbal products, or serotonergic agents such as selective serotonin reuptake inhibitors (e.g., fluoxetine, sertraline, fluvoxamine, paroxetine), have not been established. Therefore, coadministration of phentermine and these drug products is not recommended.

The following adverse reactions are described, or described in greater detail, in other sections:

- Primary pulmonary hypertension [see ]

- Valvular heart disease [see ]

- Effect on the ability to engage in potentially hazardous tasks [see ]

- Withdrawal effects following prolonged high dosage administration [see ]

The following adverse reactions to phentermine have been identified:

Cardiovascular

Primary pulmonary hypertension and/or regurgitant cardiac valvular disease, palpitation, tachycardia, elevation of blood pressure, ischemic events.

Central

Ner

vous

System

Overstimulation, restlessness, dizziness, insomnia, euphoria, dysphoria, tremor, headache, psychosis.

Gastrointestinal

Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances.

Allergic

Urticaria.

Endocrine

Impotence, changes in libido.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).