Pharmaceutical Tablets

Generic Name - Ferrous Ascorbate 100 mg + Folic Acid 1.5 mg + Cyanocobalamin 15 mcg+ Zinc 22.5 mg Tablets

Use : Most effective for the treatment of ironed deficiency & anemia inclusive of vitamin needs for the human body.

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Key Benefits are :

• Ferrous Ascorbate is an antianemic agent. It is an iron supplement, used to treat or prevent iron deficiency anemia.
• Folic Acid is a Vitamin B which helps the body makes healthy new cells. Especially for women who may get pregnant, it is very important.
• Cyanocobalamin. Its key role is the normal functioning of the brain and nervous system and for the formation of blood.
• Zinc is an essential mineral that stimulates the activity of about 100 enzymes in the body. It supports our healthy immune system, to synthesize DNA. It plays important role in healthy development of the body during adolescence, childhood and pregnancy.

Drug Class and Mechanism : Rislin (risperidone) is an atypical antipsychotic drug that is used for treating schizophrenia, bipolar mania and autism. Other atypical antipsychotic drugs include Olanzapine (Olife), Quetiapine (Taliquel), Ziprasidone , Aripiprazole  and paliperidone . Atypical antipsychotics differ from typical antipsychotics due to the lesser degree of extrapyramidal (movement) side effects and constipation.

Details :

• The exact mechanism of action of  Rislin (risperidone) is not known, but, like other anti-psychotics, it is believed that risperidone affects the way the brain works by interfering with communication among the brain's nerves. Nerves communicate with each other by making and releasing chemicals called neurotransmitters. The neurotransmitters travel to other nearby nerves where they attach to receptors on the nerves. The attachment of the neurotransmitters either stimulates or inhibits the function of the nearby nerves. Risperidone blocks several of the receptors on nerves including dopamine type 2, serotonin type 2, and alpha 2 adrenergic receptors.
• It is believed that many psychotic illnesses are caused by abnormal communication among nerves in the brain and that by altering communication through neurotransmitters, risperidone can alter the psychotic state. Risperidone was approved by the FDA in December, 1993.
• Prescription - Yes
• Preparations - Tab RISLIN® Tablets are available in  1 mg (Brown), 2 mg (orange), Rislin Plus (Red Brown), Risperidone 3 mg +Trihexyphenidyl 2 mg. strengths. rislin® tablets contain the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, propylene glycol, sodium lauryl sulfate, and starch (corn). The 1 mg,  2 mg, PLUS tablets also contain talc and titanium dioxide.
• Storage - Tablets should be kept at room temperature, 15-25 C (59-77 F)

Prescribed For : Risperidone is used to treat schizophrenia, bipolar mania [as a sole therapy or combination therapy with lithium ,  or valproate (validin, Divolin) and for the treatment of irritability associated with autistic disorder in children and adolescents. Clinical studies involving small numbers of patients have shown some benefit in using risperidone for stuttering and Tourette syndrome (non FDA-approved uses). Another non-FDA approved use of risperidone is for obsessive-compulsive disorders.

Dosing :

• Rislin (risperidone) can be administered once or twice daily. Initial dosing is generally 2 mg/day. Dose increases can occur in increments of 1-2 mg/day, as tolerated, to a recommended dose of 4-8 mg/day. In children, risperidone should be initiated at 0.5 mg once daily, and can be increased in increments of 0.5 or 1 mg/day, as tolerated, to a recommended dose of 2.5 mg/day. Risperidone can be given with or without meals. The recommended dose of Risperdal Consta is 25 mg injected into the deltoid or gluteal muscle every two weeks.
• Patients who have never received risperidone are started on oral risperidone in order to evaluate tolerability.

Drug Interactions :

• Risperidone may interfere with elimination by the kidneys of clozapine , a different type of antipsychotic medication, causing increased levels of clozapine in the blood. This could increase the risk of side effects with clozapine.
• Serotonin reuptake inhibitors such as paroxetine (Paxilin, Sertraline , and fluoxetine  when taken with risperidone causes the metabolism (breakdown) of risperidone by the liver to be inhibited, which in turn causes elevated blood levels of risperidone, and may increase the risk of adverse reactions.
• Antifungal drugs such as fluconazole , itraconazole , and ketoconazole  when taken with risperidone cause the metabolism (breakdown) of risperidone by the liver to be inhibited, which in turn causes elevated blood levels and may increase the risk of adverse reactions.

Pregnancy : There are no adequate studies of risperidone in pregnant women. Some unwanted effects have been reported in animal studies. Risperidone can be used in pregnancy if the physician feels that the benefits outweigh the potential but unknown risks.

Nursing Mothers : Rislin ( risperidone) is excreted in human breast milk. Women receiving risperidone should not breastfeed.

Side Effects :

• The most commonly-noted side effects associated with risperidone are extrapyramidal effects (sudden, often jerky, involuntary motions of the head, neck, arms, body, or eyes), dizziness, hyperactivity, tiredness, abdominal pain, fatigue, fever and nausea. Risperidone may cause a condition called orthostatic hypotension during the early phase of treatment (the first week or two). Patients who develop orthostatic hypotension have a drop in their blood pressure when they rise from a lying position and may become dizzy or even lose consciousness.
• Studies involving risperidone suggest an increased risk of hyperglycemia-related adverse reactions as seen in diabetes. Although there is no clear link between risperidone and diabetes, patients should be tested during treatment for elevated blood sugars. Additionally, persons with risk factors for diabetes, including obesity or a family history of diabetes, should have their fasting levels of blood sugar tested before starting treatment and periodically throughout treatment to detect the onset of diabetes. Any patient developing symptoms that suggest diabetes during treatment should be tested for diabetes.

Uses : This medication is used to treat schizophrenia and bipolar disorder (manic phase). It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters). Risperidone has not been shown to be safe or effective in the elderly for the treatment of delusions/hallucinations (psychosis) due to dementia.

How to Use : Take this medication by mouth exactly as prescribed. This drug may be taken with or without food. During the first few days your doctor may gradually increase your dose to allow your body to adjust to the medication. The dosage is based on your medical condition and response to therapy. Continue to take this medication as directed, even if you are feeling better and thinking more clearly. Do not take this more often or increase your dose without consulting your doctor. Your condition will not improve any faster but the risk of serious side effects will be increased. Do not stop taking this drug without your doctor's approval. Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day.

Side Effects :

• Dizziness, drowsiness, fatigue, nausea, constipation, runny nose, weight gain, nervousness, acne, dry skin, difficulty concentrating, decreased sexual ability/desire or difficulty sleeping may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly. To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position. Tell your doctor immediately if any of these serious side effects occur - fainting, rapid/pounding/irregular heartbeat, mental/mood changes, fever, muscle stiffness/spasms/twitching, sweating, uncontrolled muscle movements (e.g., tongue and facial muscles), drooling, difficulty swallowing, seizures.
• Tell your doctor immediately if any of these unlikely but serious side effects occur: chest pain, one-sided weakness, numbness in the face/arms/legs, sudden vision changes, slurred speech, confusion. This medication may in rare instances increase your blood level of a certain hormone (prolactin). In females, an increase in prolactin levels may result in unwanted breast milk, the end of menstruation or difficulty becoming pregnant. In males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.
• This drug may infrequently make your blood sugar level rise, therefore causing or worsening diabetes. This high blood sugar can rarely cause serious (sometimes fatal) conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as unusual increased thirst and urination. If you already have diabetes, be sure to check your blood sugar level regularly.
• This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.) Males: In the unlikely event you have a painful, prolonged erection, stop using this drug and seek immediate medical attention or permanent problems could occur.
• A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Warning :

• Increased Mortality in Elderly Patients with Dementia-related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of 17 placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group.
• Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality.
• The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Rislin® (risperidone) is not approved for the treatment of patients with dementia-related psychosis. [See Warnings and Precautions]

Talicarb SR (Oxcarbazepine) is an anticonvulsant and mood stabilizing drug, used primarily in the treatment of epilepsy. It is also used to treat anxiety and mood disorders, and benign motor tics. Oxcarbazepine is a structural derivative of carbamazepine, with a ketone in place of the carbon-carbon double bond on the dibenzazepine ring. This difference helps reduce the impact on the liver of metabolizing the drug, and also prevents the serious forms of anemia or agranulocytosis occasionally associated with carbamazepine. Aside from this reduction in side effects, it is thought to have the same mechanism as carbamazepine - sodium channel inhibition (presumed to be the main mechanism of action) - and is generally used to treat the same conditions.  Oxcarbazepine has recently been found to be associated with a greater enhancement in mood and reduction in anxiety symptoms than other drugs employed to treat epilepsy.

History : First synthesized in 1965, it was patent protected by Geigy in 1969 through DE2011087. It was approved for use as an anticonvulsant in Denmark in 1990, Spain in 1993, Portugal in 1997, and eventually for all other EU countries in 1999. It was approved in the US in 2000.

Pharmacology : Oxcarbazepine is a prodrug which is activated to eslicarbazepine in the liver.

Side effects :

• Oxcarbazepine causes dizziness, drowsiness, blurred or double vision, fatigue and may cause headaches, nausea, and vomiting. It can also cause hyponatremia (2.7% of patients), so blood sodium levels should be tested if the patient complains of severe fatigue.
• Some of these side effects (such as headache) are more pronounced shortly after a dose is taken and tend to fade with the passage of time (generally 60 to 90 minutes). A craving for salty foods (such as potato chips) and increased impulsiveness have also been noted. Other side effects include stomach pain; tremor; rash; diarrhea, constipation, decreased appetite; and dry mouth. Skin sensitivity to sunlight also may increase, and patients could experience severe sunburns as a result of sun exposure. The frequency of adverse effects rises above a daily dosage of 1200 mg.

Possible reproductive risks :

• Oxcarbazapine may cause oral hormonal contraceptives to be less effective.
• Increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity (embryolethality, growth retardation) were observed in the offspring of animals (rats and rabbits) treated with either oxcarbazepine or its active 10-hydroxy metabolite (MHD) during pregnancy at doses similar to the maximum recommended human dose.
• There are no adequate and well-controlled clinical studies of oxcarbazepine in pregnant women; however, oxcarbazepine is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. Given this fact, and the results of the animal studies described, it is likely that oxcarbazepine is a human teratogen. Oxcarbazepine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers : Oxcarbazepine and its active metabolite MHD are excreted in human breast milk. Because of the potential for serious adverse reactions to oxcarbazepine in nursing infants, a decision should be made about whether to discontinue nursing or to discontinue the drug in nursing women, taking into account the importance of the drug to the mother.

Talicetam (Piracetam)is a nootropic drug. It appears to enhance cognition and memory, slow brain aging, increase blood flow and oxygen to the brain, aid stroke recovery, and ameliorate Alzheimer's, Down's syndrome, dementia, and dyslexia, among other diseases and conditions. Piracetam's chemical name is 2-oxo-1-pyrrolidine acetamide; it shares the same 2-oxo-pyrrolidone base structure with 2-oxo-pyrrolidine carboxylic acid (pyroglutamate). Piracetam is a cyclic derivative of GABA. It is one of the racetams. Piracetam is prescribed by doctors for some conditions, mainly myoclonus, but is used off-label for a much wider range of applications.

Pharmacokinetics : Piracetam protects the cerebral cortex against hypoxia. It also inhibits platelet aggregation and reduces blood viscosity.

Piracetam Adverse Reactions / Piracetam Side Effects : Hyperkinesia, nervousness, depression, diarrhoea, rashes. CNS stimulation, sleep disturbances, dizziness, excitement, insomnia, somnolence, weight gain.

Special Precautions : Avoid abrupt withdrawal. Impaired renal function. Cardiac disorders. Haemostatic disorders. Patients who have recently undergone major surgery. Elderly.

Other Drug Interactions : May increase prothrombin time in patients who are on warfarin.

Dosage :

• Oral Adjunct in cortical myoclonus
• Adult - 7.2 g daily in 2-3 divided doses, increased by 4.8 g/day every 3-4 days. Max dose - 20 g daily.

Food(before/after) Should be taken with food. (Take before meals.)

List of Contraindications

• Piracetam and Pregnancy
• Contraindicated in pregnancy
• Piracetam and Lactation
• Contraindicated in lactation
• Piracetam and Other Contraindications
• Hepatic and severe renal impairment. Cerebral haemorrhage. Pregnancy and lactation.

Talimem  contains a combination of donepezil and memantine. Donepezil improves the function of nerve cells in the brain. It works by preventing the breakdown of a chemical called acetylcholine People with dementia usually have lower levels of this chemical, which is important for the processes of memory, thinking, and reasoning. Memantine reduces the actions of chemicals in the brain that may contribute to the symptoms of Alzheimer's disease.

Details :

• Talimem  is used to treat moderate to severe dementia of the Alzheimer's type.
• Talimem   is not a cure for Alzheimer's disease. This condition will progress over time, even in people who take donepezil.
• Before taking this medicine
• You should not use Talimem if you are allergic to donepezil or memantine.
• How should I take Talimem ?
• Take Talimem exactly as prescribed by your doctor .

Thimore-100 (Thiamine) is a vitamin, also called vitamin B1. Vitamin B1 is found in many foods including yeast, cereal grains, beans, nuts, and meat. It is often used in combination with other B vitamins, and found in many vitamin B complex products. Vitamin B complexes generally include vitamin B1 (thiamine), vitamin B2 (riboflavin), vitamin B3 (niacin/niacinamide), vitamin B5 (pantothenic acid), vitamin B6 (pyridoxine), vitamin B12 (cyanocobalamin), and folic acid. However, some products do not contain all of these ingredients and some may include others, such as biotin, para-aminobenzoic acid (PABA), choline bitartrate, and inositol.

Details :

• People take thiamine for conditions related to low levels of thiamine (thiamine deficiency syndromes), including beriberi and inflammation of the nerves (neuritis) associated with pellagra or pregnancy.
• Thimore-100 (Thiamine) is also used for digestive problems including poor appetite, ulcerative colitis, and ongoing diarrhea.
• Thimore-100 (Thiamine) is also used for AIDS and boosting the immune system, diabetic pain, heart disease, alcoholism, aging, a type of brain damage called cerebellar syndrome, canker sores, vision problems such as cataracts and glaucoma, motion sickness, and improving athletic performance. Other uses include preventing cervical cancer and progression of kidney disease in patients with type 2 diabetes.
• Some people use thiamine for maintaining a positive mental attitude; enhancing learning abilities; increasing energy; fighting stress; and preventing memory loss, including Alzheimer's disease.
• Healthcare providers give thiamine shots for a memory disorder called Wernicke's encephalopathy syndrome, other thiamine deficiency syndromes in critically ill people, alcohol withdrawal, and coma.

How effective is it? : Natural Medicines Comprehensive Database rates effectiveness based on scientific evidence according to the following scale: Effective, Likely Effective, Possibly Effective, Possibly Ineffective, Likely Ineffective, Ineffective, and Insufficient Evidence to Rate.

The effectiveness ratings Thimore (vitamin B1) are as follows:

• Effective for Metabolic disorders. Taking thiamine by mouth helps correct metabolic disorders associated with genetic diseases, including Leigh's disease, maple syrup urine disease, and others.
• Thiamine deficiency. Taking thiamine by mouth helps prevent and treat thiamine deficiency.
• Brain disorder due to thiamine deficiency (Wernicke-Korsakoff syndrome). Thiamine helps decrease the risk and symptoms of a specific brain disorder called Wernicke-Korsakoff syndrome (WKS).
• This brain disorder is related to low levels of thiamine (thiamine deficiency) and is often seen in alcoholics. Between 30% and 80% of alcoholics are believed to have thiamine deficiency. Giving thiamine shots seems to help decrease the risk of developing WKS and decrease symptoms of WKS during alcohol withdrawal.
• Possibly effective for
  
  • Cataracts. High thiamine intake as part of the diet is associated with a reduced risk of developing cataracts.
  • Kidney disease in people with diabetes. Early research shows that taking high-dose thiamine (100 mg three times daily) for 3 months decreases the amount of albumin in the urine in people with type 2 diabetes. Albumin in the urine is an indication of kidney damage.
  • Painful menstruation (dysmenorrhea). Early research suggests that taking thiamine for 90 days stops pain associated with menstruation in girls 12-21 years-old.
• Possibly ineffective for : Repelling mosquitos. Some research shows that taking B vitamins, including thiamine, does not help repel mosquitos.
• Insufficient evidence to rate effectiveness for.
  
  • Athletic performance. Some research suggests that taking thiamine together with pantethine and pantothenic acid (vitamin B5) does not improve muscle strength or endurance in athletes.
• Preventing cervical cancer. Some research suggests that increasing intake of thiamine from dietary and supplement sources, along with other folic acid, riboflavin, and vitamin B12, might decrease the risk of precancerous spots on the cervix.Poor appetite.
  • Ulcerative colitis.
  • Chronic diarrhea.
  • Stomach problems.
  • Brain conditions.
  • AIDS.
  • Heart disease.
  • Alcoholism.
  • Stress.
  • Aging.
  • Canker sores. Other conditions.
  • More evidence is needed to rate thiamine for these uses.

How does it work? : Thiamine is required by our bodies to properly use carbohydrates.

Are there safety concerns? : Thiamine is Likely Safe when taken by mouth in appropriate amounts, although rare allergic reactions and skin irritation have occurred. It is also Likely Safe when given appropriately intravenously (by IV) by a healthcare provider. Thiamine shots are an FDA-approved prescription product. Thiamine might not properly enter the body in some people who have liver problems, drink a lot of alcohol, or have other conditions.

Special precautions & warnings : Pregnancy and breast-feeding: Thiamine is Likely Safe for pregnant or breast-feeding women when taken in the recommended amount of 1.4 mg daily. Not enough is known about the safety of using larger amounts during pregnancy or breast-feeding.

Are there interactions with medications?

• It is not known if this product interacts with any medicines.
• Before taking this product, talk with your health professional if you take any medications.

Are there interactions with herbs and supplements?

• Areca : Areca (betel) nuts change thiamine chemically so it doesn't work as well. Regular, long-term chewing of betel nuts may contribute to thiamine deficiency.
• Horsetail : Horsetail (Equisetum) contains a chemicalthat can destroy thiamine in the stomach, possibly leading to thiamine deficiency. The Canadian government requires that equisetum-containing products be certified free of this chemical. Stay on the safe side, and don't use horsetail if you are at risk for thiamine deficiency.

Are there interactions with foods?

• Coffee and tea : Chemicals in coffee and tea called tannins can react with thiamine, converting it to a form that is difficult for the body to take in. This could lead to thiamine deficiency. Interestingly, thiamine deficiency has been found in a group of people in rural Thailand who drink large amounts of tea (>1 liter per day) or chew fermented tea leaves long-term. However, this effect hasn't been found in Western populations, despite regular tea use. Researchers think the interaction between coffee and tea and thiamine may not be important unless the diet is low in thiamine or vitamin C. Vitamin C seems to prevent the interaction between thiamine and the tannins in coffee and tea.
• Seafood : Raw freshwater fish and shellfish contain chemicals that destroy thiamine. Eating a lot of raw fish or shellfish can contribute to thiamine deficiency. However, cooked fish and seafood are OK. They don't have any effect on thiamine, since cooking destroys the chemicals that harm thiamine.

What dose is used? The following doses have been studied in scientific research :

• By Mouth :
  
  • For adults with somewhat low levels of thiamine in their body (mild thiamine deficiency): the usual dose of thiamine is 5-30 mg daily in either a single dose or divided doses for one month. The typical dose for severe deficiency can be up to 300 mg per day.
  • For reducing the risk of getting cataracts : a daily dietary intake of approximately 10 mg of thiamine.
  • As a dietary supplement in adults, 1-2 mg of thiamine per day is commonly used. The daily recommended dietary allowances (RDAs) of thiamine are: Infants 0-6 months, 0.2 mg; infants 7-12 months, 0.3 mg; children 1-3 years, 0.5 mg; children 4-8 years, 0.6 mg; boys 9-13 years, 0.9 mg; men 14 years and older, 1.2 mg; girls 9-13 years, 0.9 mg; women 14-18 years, 1 mg; women over 18 years, 1.1 mg; pregnant women, 1.4 mg; and breast-feeding women, 1.5 mg.
• By Injection : Healthcare providers give thiamine shots for treating and preventing symptoms of alcohol withdrawal (Wernicke-Korsakoff syndrome).

Other Names : Aneurine Hydrochloride, Antiberiberi Factor, Antiberiberi Vitamin, Antineuritic Factor, Antineuritic Vitamin, B Complex Vitamin, Chlorhydrate de Thiamine, Chlorure de Thiamine, Complexe de Vitamine B, Facteur Anti-beriberi, Facteur Antineuritique, Hydrochlorure de Thiamine, Mononitrate de Thiamine, Nitrate de Thiamine, Thiamine Chloride, Thiamine HCl, Thiamine Hydrochloride, Thiamin Mononitrate, Thiamine Mononitrate, Thiamine Nitrate, Thiaminium Chloride Hydrochloride, Tiamina, Vitamin B1, Vitamin B-1, Vitamina B1, Vitamine Anti-beriberi, Vitamine Antineuritique, Vitamine B1.

Mandrive for ED+BPH (erectile dysfunction + symptoms of benign prostatic hyperplasia)

Pharmacology : Inhibition of phosphodiesterase type 5 (PDE5) by tadalafil increases the concentrations of cyclic guanosine monophosphate (cGMP), resulting in relaxation of pulmonary vascular smooth muscle cells and vasodilation of the pulmonary vascular bed.

Mandrive-20 : Enhances the effect of nitric oxide at the nerve ending and endothelial cells in the corpus cavernosum by inhibiting PDE5 in the corpus cavernosum of the penis. This results in vasodilation, increased inflow of blood into the corporus cavernosum, and ensuing penile erection upon sexual stimulation.FDA Drug Approvals 2013

Pharmacokinetics

• Absorption
• Bioavailability undetermined. T max is 2 to 8 h.
• Steady state is attained within 5 days of once-daily dosing.

Distribution : Tadalafil is 94% protein bound

Metabolism : Predominantly metabolized by CYP3A4 to a catechol metabolite, which undergoes further metabolism to the major circulating metabolite, methylcatechol glucuronide.

Elimination : The terminal half-life is 15 h to 17.5 h. Tadalafil is excreted predominantly as metabolites, mainly in the feces (approximately 61%) and to a lesser degree in the urine (approximately 36%).

Special Populations :

• Renal Function Impairment : Tadalafil exposure (AUC) doubled in subjects with CrCl 31 to 80 mL/min. In patients with ESRD on hemodialysis, there was a 2-fold increase in C max and 2.7- to 4.8-fold increase in AUC.
• Hepatic Function Impairment : Tadalafil exposure (AUC) after a 10 mg dose in patients with mild or moderate hepatic impairment (Child-Pugh class A or B) was comparable with exposure in healthy subjects. There are insufficient data for subjects with severe hepatic impairment.
• Elderly : Subjects older than 65 y have a 25% higher exposure compared with subjects 19 to 45 y of age.
• Children : Tadalafil has not been evaluated in patients younger than 18 y.
• Gender : No clinically relevant differences in AUC and C max have been observed.
• Race : No differences in the typical exposure to tadalafil have been identified among different ethnic groups.
• Diabetes mellitus  : AUC was reduced approximately 19% and C max was 5% lower in patients with diabetes mellitus than in healthy subjects.
• Indications and Usage : Treatment of pulmonary arterial hypertension ; treatment of erectile dysfunction, treatment of benign prostatic hyperplasia , and the treatment of combined erectile dysfunction and BPH.

Unlabeled Uses : Raynaud phenomenon.

Contraindications : Administration with organic nitrates (regularly and/or intermittently); serious hypersensitivity to tadalafil.

Dosage and Administration :

• Benign Prostatic Hyperplasia (With or Without Concomitant Erectile Dysfunction)
• Adults
• PO 5 mg once daily, taken at approximately the same time every day without regard to sexual activity.

Pulmonary Arterial Hypertension :

• Adults
• PO 40 mg once daily.

Erectile Dysfunction :

• Adults For use as needed
• PO 10 mg prior to anticipated sexual activity. The dose may be adjusted to 5 or 20 mg based on efficacy and tolerability. The max recommended frequency is once per day for most patients.

Once-daily use : PO Start with 2.5 mg once daily, taken at approximately the same time each day, without regard to timing of sexual activity. The dosage may be increased to 5 mg daily based on individual efficacy and tolerability.