Guanfacine (Guanfacine)

Trade Name : Guanfacine

Teva Pharmaceuticals USA, Inc.

TABLET, EXTENDED RELEASE

Strength 1 mg/1

GUANFACINE HYDROCHLORIDE Central alpha-2 Adrenergic Agonist [EPC],Adrenergic alpha2-Agonists [MoA]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Guanfacine (Guanfacine) which is also known as Guanfacine and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 1 mg/1 per ml. Read more

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Guanfacine extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications .u00a0n
Guanfacine extended-release tablets are a central alpha-adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications (, ).

No data

Recommended dose: 1 mg to 7 mg (0.05 to 0.12 mg/kg target weight based dose range) once daily in the morning or evening based on clinical response and tolerability ().
Begin at a dose of 1 mg once daily and adjust in increments of no more than 1 mg/week ().
Do not crush, chew or break tablets before swallowing ().
Do not administer with high-fat meals, because of increased exposure ().
Do not substitute for immediate-release guanfacine tablets on a mg-per-mg basis, because of differing pharmacokinetic profiles ().
If switching from immediate-release guanfacine, discontinue that treatment and titrate with guanfacine extended-release tablets as directed ().
When discontinuing, taper the dose in decrements of no more than 1 mg every 3 to 7 days to avoid rebound hypertension ().

1 mg, 2 mg, 3 mg and 4 mg extended-release tablets
Extended-release tablets: 1 mg, 2 mg, 3 mg and 4 mg ()

Guanfacine extended-release tablets are contraindicated in patients with a history of a hypersensitivity reaction to guanfacine extended-release tablets or its inactive ingredients, or other products containing guanfacine. Rash and pruritus have been reported.
History of hypersensitivity to guanfacine extended-release tablets, its inactive ingredients, or other products containing guanfacine ().

No data

Hypotension, bradycardia, syncope: Titrate slowly and monitor vital signs frequently in patients at risk for hypotension, heart block, bradycardia, syncope, cardiovascular disease, vascular disease, cerebrovascular disease or chronic renal failure. Measure heart rate and blood pressure prior to initiation of therapy, following dose increases, and periodically while on therapy. Avoid concomitant use of drugs with additive effects unless clinically indicated. Advise patients to avoid becoming dehydrated or overheated ().
Sedation and somnolence: Occur commonly with guanfacine extended-release tablets. Consider the potential for additive sedative effects with CNS depressant drugs. Caution patients against operating heavy equipment or driving until they know how they respond to guanfacine extended-release tablets ().
Cardiac Conduction Abnormalities: May worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. Titrate slowly and monitor vital signs frequently ().
Rebound Hypertension: Abrupt discontinuation of guanfacine extended-release tablets can lead to clinically significant and persistent rebound hypertension. Subsequent hypertensive encephalopathy was also reported. To minimize the risk of rebound hypertension upon discontinuation, the total daily dose of guanfacine extended-release tablets should be tapered in decrements of no more than 1 mg every 3 to 7 days ().

The following serious adverse reactions are described elsewhere in the labeling:
Most common adverse reactions (u2265 5% and at least twice placebo rate) in fixed-dose monotherapy ADHD trials in children and adolescents (6 to 17 years): hypotension, somnolence, fatigue, nausea, and lethargy ().
Flexible dose-optimization ADHD trials in children (6 to 12 years) and adolescents (13 to 17 years): somnolence, hypotension, abdominal pain, insomnia, fatigue, dizziness, dry mouth, irritability, nausea, vomiting, and bradycardia ().
Adjunctive treatment to psychostimulant ADHD trial in children and adolescents (6 to 17 years): somnolence, fatigue, insomnia, dizziness, and abdominal pain ().
To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Table 14 contains clinically important drug interactions with guanfacine extended-release tabletsn
Table 14: Clinically Important Drug Interactions: Effect of other Drugs on Guanfacine Extended-Release Tablets

Strong and moderate CYP3A4 inhibitors increase guanfacine exposure. Decrease guanfacine to 50% of target dosage when coadministered with strong and moderate CYP3A4 inhibitors ().
Strong and moderate CYP3A4 inducers decrease guanfacine exposure. Based on patient response, consider titrating guanfacine dosage up to double the target dosage over 1 to 2 weeks ().

No data

Guanfacine extended-release tablets are not a controlled substance and have no known potential for abuse or dependence.

Symptoms
Postmarketing reports of guanfacine overdosage indicate that hypotension, drowsiness, lethargy, and bradycardia have been observed following overdose. Initial hypertension may develop early and may be followed by hypotension. Similar symptoms have been described in voluntary reports to the American Association of Poison Control Centeru2019s National Poison Data System. Miosis of the pupils may be noted on examination. No fatal overdoses of guanfacine have been reported in published literature.
Treatment
Consult a Certified Poison Control Center by calling 1-800-222-1222 for up-to-date guidance and advice.
Management of guanfacine extended-release tablets overdose should include monitoring for and the treatment of initial hypertension, if that occurs, as well as hypotension, bradycardia, lethargy and respiratory depression. Children and adolescents who develop lethargy should be observed for the development of more serious toxicity including coma, bradycardia and hypotension for up to 24 hours, due to the possibility of delayed onset hypotension.

Guanfacine extended-release tablets are a once-daily, extended-release formulation of guanfacine hydrochloride (HCl), USP in a matrix tablet formulation for oral administration only. The chemical designation is N-amidino-2-(2,6-dichlorophenyl) acetamide monohydrochloride. The chemical structure is:
CHClNOu2022HCl M.W. 282.55
Guanfacine HCl, USP is a white to off-white crystalline powder, sparingly soluble in water (approximately 1 mg/mL) and alcohol and slightly soluble in acetone. The only organic solvent in which it has relatively high solubility is methanol (> 30 mg/mL). Each tablet contains guanfacine HCl, USP equivalent to 1 mg, 2 mg, 3 mg, or 4 mg of guanfacine base. The tablets also contain colloidal silicon dioxide, crospovidone, fumaric acid, glyceryl dibehenate, lactose monohydrate, methacrylic acid and ethyl acrylate copolymer, microcrystalline cellulose, and povidone.

No data

Carcinogenesis
No carcinogenic effect of guanfacine was observed in studies of 78 weeks in mice or 102 weeks in rats at doses up to 6.8 times the maximum recommended human dose of 0.12 mg/kg/day on a mg/m basis.
Mutagenesis
Guanfacine was not genotoxic in a variety of test models, including the Ames test and an chromosomal aberration test; however, a marginal increase in numerical aberrations (polyploidy) was observed in the latter study.
Impairment of Fertility
No adverse effects were observed in fertility studies in male and female rats at doses up to 22 times the maximum recommended human dose on a mg/m basis.

Efficacy of guanfacine extended-release tablets in the treatment of ADHD was established in children and adolescents (6 to 17 years) in:
Studies 1 and 2: Fixed-dose Guanfacine Extended-Release Tablets Monotherapy
Study 1 (301 study) was a double-blind, placebo-controlled, parallel-group, fixed-dose study, in which efficacy of once daily dosing with guanfacine extended-release tablets (2 mg, 3 mg and 4 mg) was evaluated for 5 weeks (n = 345) in children and adolescents aged 6 to 17 years. Study 2 (304 study) was a double-blind, placebo-controlled, parallel-group, fixed-dose study, in which efficacy of once daily dosing with guanfacine extended-release tablets (1 mg, 2 mg, 3 mg and 4 mg) was evaluated for 6 weeks (n = 324) in children and adolescents aged 6 to 17 years. In both studies, randomized patients in 2 mg, 3 mg and 4 mg dose groups were titrated to their target fixed dose, and continued on the same dose until a dose tapering phase started. The lowest dose of 1 mg used in Study 2 was not randomized to patients weighing more than 50 kg. Patients who weighed less than 25 kg were not included in either study.
Signs and symptoms of ADHD were evaluated on a once weekly basis using the clinician administered and scored ADHD Rating Scale (ADHD-RS-IV), which includes both hyperactive/impulsive and inattentive subscales. The primary efficacy outcome was the change from baseline to endpoint in ADHD-RS-IV total scores. Endpoint was defined as the last post-randomization treatment week for which a valid score was obtained prior to dose tapering (up to Week 5 in Study 1 and up to Week 6 in Study 2).
The mean reductions in ADHD-RS-IV total scores at endpoint were statistically significantly greater for guanfacine extended-release tablets compared to placebo for Studies 1 and 2. Placebo-adjusted changes from baseline were statistically significant for each of the 2 mg, 3 mg, and 4 mg guanfacine extended-release tablets randomized treatment groups in both studies, as well as the 1 mg guanfacine extended-release tablets treatment group that was included only in Study 2 (see Table 16).
Dose-responsive efficacy was evident, particularly when data were examined on a weight-adjusted (mg/kg) basis. When evaluated over the dose range of 0.01 to 0.17 mg/kg/day, clinically relevant improvements were observed beginning at doses in the range 0.05 to 0.08 mg/kg/day. Doses up to 0.12 mg/kg/day were shown to provide additional benefit.
In the monotherapy trials (Studies 1 and 2), subgroup analyses were performed to identify any differences in response based on gender or age (6 to 12 vs. 13 to 17). Analyses of the primary outcome did not suggest any differential responsiveness on the basis of gender. Analyses by age revealed a statistically significant treatment effect only in the 6 to 12 age subgroup. Due to the relatively small proportion of adolescent patients (ages 13 to 17) enrolled into these studies (approximately 25%), these data may not have been sufficient to demonstrate efficacy in the adolescent patients. In these studies, patients were randomized to a fixed dose of guanfacine extended-release tablets rather than optimized by body weight. Therefore, some adolescent patients were randomized to a dose that might have resulted in relatively lower plasma guanfacine concentrations compared to the younger patients. Over half (55%) of the adolescent patients received doses of 0.01 to 0.04 mg/kg. In studies in which systematic pharmacokinetic data were obtained, there was a strong inverse correlation between body weight and plasma guanfacine concentrations.
Study 3: Flexible-dose Guanfacine Extended-Release Tablets as Adjunctive Therapy to Psychostimulants
Study 3 (313 study) was a double-blind, randomized, placebo-controlled, dose-optimization study, in which efficacy of once daily optimized dosing (morning or evening) with guanfacine extended-release tablets (1 mg, 2 mg, 3 mg and 4 mg), when coadministered with psychostimulants, was evaluated for 8 weeks, in children and adolescents aged 6 to 17 years with a diagnosis of ADHD, with a sub-optimal response to stimulants (n = 455). Patients were started at the 1 mg guanfacine extended-release tablets dose level and were titrated weekly over a 5 week dose-optimization period to an optimal guanfacine extended-release tablets dose not to exceed 4 mg/day based on tolerability and clinical response. The dose was then maintained for a 3 week dose maintenance period before entry to 1 week of dose tapering. Patients took guanfacine extended-release tablets either in the morning or the evening while maintaining their current dose of psychostimulant treatment given each morning. Allowable psychostimulants in the study were ADDERALL XR, VYVANSE, CONCERTA, FOCALIN XR, RITALIN LA, METADATE CDor FDA-approved generic equivalents.
Symptoms of ADHD were evaluated on a weekly basis by clinicians using the ADHD Rating Scale (ADHD-RS-IV), which includes both hyperactive/impulsive and inattentive subscales. The primary efficacy outcome was the change from baseline to endpoint in ADHD-RS-IV total scores. Endpoint was defined as the last post-randomization treatment week prior to dose tapering for which a valid score was obtained (up to Week 8).
Mean reductions in ADHD-RS-IV total scores at endpoint were statistically significantly greater for guanfacine extended-release tablets given in combination with a psychostimulant compared to placebo given with a psychostimulant for Study 3, for both morning and evening guanfacine extended-release tablets dosing (see Table 17). Nearly two-thirds (64.2%) of patients reached optimal doses in the 0.05 to 0.12 mg/kg/day range.
Studies 4, 5 and 6: Flexible-dose Guanfacine Extended-Release Tablets Monotherapy
Study 4 (314 study) was a double-blind, randomized, placebo-controlled, dose-optimization study, in which efficacy of once daily dosing (morning or evening) with guanfacine extended-release tablets (1 mg, 2 mg, 3 mg, and 4 mg) was evaluated for 8 weeks in children aged 6 to 12 years (n = 340).
Signs and symptoms of ADHD were evaluated on a once weekly basis using the clinician administered and scored ADHD Rating Scale (ADHD-RS-IV), which includes both hyperactive/impulsive and inattentive subscales. The primary efficacy outcome was the change from baseline score at endpoint on the ADHD-RS-IV total scores. Endpoint was defined as the last post-randomization treatment week for which a valid score was obtained prior to dose tapering (up to Week 8).
Mean reductions in ADHD-RS-IV total scores at endpoint were statistically significantly greater for guanfacine extended-release tablets compared to placebo in both AM and PM dosing groups of guanfacine extended-release tablets (see Table 17).
Study 5 (312 study) was a 15 week, double-blind, randomized, placebo-controlled, dose-optimization study conducted in adolescents aged 13 to 17 years (n = 314) to evaluate the efficacy and safety of guanfacine extended-release tablets (1 to 7 mg/day; optimized dose range of 0.05 to 0.12 mg/kg/day) in the treatment of ADHD as measured by the ADHD Rating Scale-IV (ADHD-RS-IV). Patients receiving guanfacine extended-release tablets showed statistically significantly greater improvement on the ADHD-RS-IV total score compared with patients receiving placebo (see Table 17).
Study 6 (316 study) was a 12 week (for children aged 6 to 12) or 15 week (for adolescents aged 13 to 17), randomized, double-blind, parallel-group, placebo- and active-reference, dose-optimization study conducted in pediatric patients (children and adolescents aged 6 to 17 years old inclusive) (n = 337) to assess the efficacy and safety of once-daily dosing (children: 1 to 4 mg/day, adolescents: 1 to 7 mg/day; optimized dose range of 0.05 to 0.12 mg/kg/day) in the treatment of ADHD. Guanfacine extended-release tablets were statistically superior to placebo on symptoms of ADHD in patients 6 to 17 years as measured by change from baseline in ADHD-RS-IV total scores (see Table 17).
Study 7: Long-Term Maintenance of Guanfacine Extended-Release Tablets Efficacy
Study 7 (315 study) was a double-blind, placebo-controlled, randomized withdrawal trial in pediatric patients aged 6 to 17 years with DSM-IV-TR diagnosis of ADHD. The study consisted of an open-label phase, including a 7 week dose optimization period to titrate patients to an optimal dose (maximum 4 mg/day for children and 7 mg/day for adolescents; optimized dose range: 0.05 to 0.12 mg/kg/day) and a 6 week dose maintenance period. There were 526 patients included in the open-label phase. Among those, 315 patients who met response criteria in the open-label phase were then randomized (1:1, guanfacine extended-release tablets:placebo) in a 26 week, double-blind, randomized withdrawal phase. The response criteria were defined by u2265 30% reduction in ADHD-RS-IV total score and a Clinical Global Impression-Improvement (CGI-I) score of 1 or 2 during the open-label phase. A statistically significantly lower proportion of treatment failures occurred among guanfacine extended-release tablets patients compared to placebo at the end of the randomized withdrawal period (Figure 4). Treatment failure was defined as a u2265 50% increase (worsening) in ADHD-RS-IV total score and a u2265 2-point increase in Clinical Global Impression-Severity (CGI-S) score. Patients who met the treatment failure criteria on two consecutive visits or discontinued for any reason were classified as treatment failure.
Figure 4: Kaplan-Meier Estimation of Proportion of Patients with Treatment Failure for Children and Adolescents Ages 6 to 17 (Study 7)

Guanfacine extended-release tablets are supplied in 1 mg, 2 mg, 3 mg, and 4 mg strength extended-release tablets.
1 mg u2013 white to off-white, oval-shaped, unscored, biconvex tablets debossed with u201cTEVAu201d on one side and u201c5960u201d on the other side, available in bottles of 100 (NDC 0093-5960-01).
2 mg u2013 white to off-white, oval-shaped, unscored, biconvex tablets debossed with u201cTEVAu201d on one side and u201c5961u201d on the other side, available in bottles of 100 (NDC 0093-5961-01).
3 mg u2013 white to off-white, oval-shaped, unscored, biconvex tablets debossed with u201cTEVAu201d on one side and u201c5963u201d on the other side, available in bottles of 100 (NDC 0093-5963-01).
4 mg u2013 white to off-white, oval-shaped, unscored, biconvex tablets debossed with u201cTEVAu201d on one side and u201c5964u201d on the other side, available in bottles of 100 (NDC 0093-5964-01).
Storage
Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Dosing and Administration
Instruct patients to swallow guanfacine extended-release tablets whole with water, milk or other liquid. Patients should not take guanfacine extended-release tablets together with a high-fat meal, since this can raise blood levels of guanfacine extended-release tablets. Instruct the parent or caregiver to supervise the child or adolescent taking guanfacine extended-release tablets and to keep the bottle of tablets out of reach of children.
Advise patients not to abruptly discontinue guanfacine extended-release tablets as abrupt discontinuation can result in clinically significant rebound hypertension. Concomitant stimulant use and abrupt discontinuation of guanfacine extended-release tablets may increase this hypertensive response. Instruct patients on how to properly taper the dose to minimize the risk of rebound hypertension n
Adverse Reactions
Advise patients that sedation can occur, particularly early in treatment or with dose increases. Caution against operating heavy equipment or driving until they know how they respond to treatment with guanfacine extended-release tablets. Headache and abdominal pain can also occur. If any of these symptoms persist, or other symptoms occur, the patient should be advised to discuss the symptoms with the health care provider.
Advise patients to avoid becoming dehydrated or overheated, which may potentially increase the risks of hypotension and syncope . Advise patients to avoid use with alcohol.
Pregnancy Registry
Advise patients that there is a pregnancy exposure registry that monitors pregnancy outcomes in patients exposed to guanfacine extended-release tablets during pregnancy .
Lactation
Advise breastfeeding mothers to monitor infants exposed to guanfacine through breastmilk for sedation, lethargy and poor feeding .
All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.
Distributed By:n North Wales, PA 19454
Rev. G 1/2020

Guanfacine
Extended-Release Tablets
Read the Patient Information that comes with guanfacine extended-release tablets before you start taking them and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
What are guanfacine extended-release tablets?
Guanfacine extended-release tablets are a prescription medicine used to treat the symptoms of attention deficit hyperactivity disorder (ADHD). Guanfacine extended-release tablets may be used alone or with ADHD stimulant medicines.
Guanfacine extended-release tablets are not a central nervous system (CNS) stimulant.n It is not known if guanfacine extended-release tablets are safe and effective in children younger than 6 years of age.n n n
Do not take guanfacine extended-release tablets if you are allergic to guanfacine or any of the ingredients in guanfacine extended-release tablets. See the end of this leaflet for a complete list of ingredients in guanfacine extended-release tablets.n
What should I tell my doctor before taking guanfacine extended-release tablets?
Before you take guanfacine extended-release tablets, tell your doctor if you:
Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Guanfacine extended-release tablets may affect the way other medicines work, and other medicines may affect how guanfacine extended-release tablets work.
Especially tell your doctor if you take:
Ask your doctor or pharmacist for a list of these medicines, if you are not sure.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.
How should I take guanfacine extended-release tablets?
What should I avoid while taking guanfacine extended-release tablets?
What are the possible side effects of guanfacine extended-release tablets?
Guanfacine extended-release tablets may cause serious side effects including:
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of guanfacine extended-release tablets include:
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of guanfacine extended-release tablets. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store guanfacine extended-release tablets?
Keep guanfacine extended-release tablets and all medicines out of the reach of children.
General Information about the safe and effective use of guanfacine extended-release tablets
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use guanfacine extended-release tablets for a condition for which they were not prescribed. Do not give guanfacine extended-release tablets to other people, even if they have the same symptoms that you have. They may harm them.
This leaflet summarizes the most important information about guanfacine extended-release tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about guanfacine extended-release tablets that is written for health professionals.
For more information about guanfacine extended-release tablets, go to or call 1-888-838-2872.
What are the ingredients in guanfacine extended-release tablets?
Active ingredient:
Inactive ingredients:
This Patient Information has been approved by the U.S. Food and Drug Administration.
Distributed By:n North Wales, PA 19454
Rev. E 1/2020

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Guanfacine (Guanfacine)

Trade Name : Guanfacine

TABLET, EXTENDED RELEASE

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Guanfacine (Guanfacine)

Trade Name : Guanfacine

TABLET, EXTENDED RELEASE

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Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Desogestrel And Ethinyl Estradiol (Emoquette)

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