Guanfacine Extended-Release Tablets 1mg

Guanfacine Extended-Release Tablets 1mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

1. Guanfacine Extended-Release Tablets 1mg
2. Guanfacine Extended-Release Tablets 2mg
3. Guanfacine Extended-Release Tablets 3mg
4. Guanfacine Extended-Release Tablets 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Guanfacine Extended-Release Tablets 1mg
Each Extended-Release tablet contains:
Guanfacine Hydrochloride USP
Equivalent to Guanfacine………….1mg
Excipients…………………………………q.s
Color: Sunset yellow FCF

2. Guanfacine Extended-Release Tablets 2mg
Each Extended-Release tablet contains:
Guanfacine Hydrochloride USP
Equivalent to Guanfacine…………2mg
Excipients………………………………….q.s
Color: Tartrazine yellow

3. Guanfacine Extended-Release Tablets 3mg
Each Extended-Release tablet contains:
Guanfacine Hydrochloride USP
Equivalent to Guanfacine…………3mg
Excipients…………………………………q.s
Color: Orange G

4. Guanfacine Extended-Release Tablets 4mg
Each Extended-Release tablet contains:
Guanfacine Hydrochloride USP
Equivalent to Guanfacine……………4mg
Excipients………………………………………q.s
Color: Resorcin brown

THERAPEUTIC INDICATIONS:

Guanfacine is used to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defines in the USP using a child-resistant closure.
Keep container tightly closed.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.

Dosage: As directed by the Physician

Attach dispensing label as per end country.

Guanfacine Extended-Release (ER) Tablets 1mg – Manufacturer, Supplier & Exporter: Taj Pharma India Ltd. (300 words)

Taj Pharma India Ltd. is a leading WHO-GMP certified pharmaceutical manufacturer, supplier, and exporter of Guanfacine Extended-Release (ER) Tablets 1mg, a non-stimulant medication used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children and adolescents. Operating from its state-of-the-art manufacturing facility located at Sarigam, G.I.D.C., Valsad, Gujarat, India, Taj Pharma ensures world-class quality, safety, and compliance standards in every formulation.

The company’s advanced tablet production unit is equipped with PIC/S, ISO 9001:2018, and GLP-compliant systems, ensuring consistency, efficacy, and stability of extended-release formulations. Each batch of Guanfacine ER 1mg undergoes rigorous quality control and stability testing, supported by a professional R&D team with expertise in controlled-release technology and regulatory documentation.

As a trusted global supplier and exporter, Taj Pharma caters to both domestic and international markets, including Asia, the Middle East, Africa, CIS, and Latin America. The company provides full regulatory support, including CTD/ACTD dossiers, stability data, Certificates of Analysis (CoA), and WHO-GMP certificates for global registrations. Taj Pharma’s export operations follow Good Distribution Practices (GDP), ensuring timely delivery and compliance with importing country regulations.

Guanfacine ER Tablets 1mg produced by Taj Pharma are packed under controlled conditions, ensuring product integrity, moisture protection, and long shelf life. Taj Pharma offers customized packaging options—blister or bottle packs—to meet partner country labeling and regulatory requirements.

With a commitment to innovation, affordability, and therapeutic excellence, Taj Pharma India Ltd. stands among the most reliable manufacturers, suppliers, and exporters of Guanfacine ER 1mg Tablets from India. The company’s focus on quality manufacturing, robust global presence, and technical expertise makes it an ideal partner for pharmaceutical importers, distributors, and government tenders worldwide.

🌐 Website: www.tajpharmaindia.com
📞 Email: info@tajpharma.com | ☎ +91 84484 44095

Guanfacine Extended-Release (ER) Tablets 1mg is a prescription medication primarily used in the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in children and adolescents. It belongs to a class of drugs known as centrally acting alpha-2A adrenergic receptor agonists.

Unlike stimulant medications, guanfacine works indirectly to improve attention and reduce impulsivity and hyperactivity. It also has calming and sedating effects, making it useful for behavioral dysregulation and sleep issues.

🔬 Pharmacological Class

• Drug Class: Alpha-2 adrenergic receptor agonist

• Mechanism of Action: Selectively stimulates alpha-2A receptors in the prefrontal cortex, leading to reduced sympathetic nerve impulses and increased regulation of attention, emotion, and behavior.

📋 Indications (Uses)

Guanfacine ER 1mg is FDA-approved for:

• ADHD in children and adolescents aged 6–17 years

Off-label uses include:

• Sleep disorders (especially in neurodevelopmental conditions)

• Tic disorders and Tourette’s syndrome

• Oppositional Defiant Disorder (ODD)

• Generalized Anxiety Disorder (GAD)

• PTSD, autism-related aggression, and impulsivity

• Sometimes used as an adjunct to stimulant therapy

🧠 How It Works

Guanfacine activates post-synaptic alpha-2A receptors in the prefrontal cortex, which is responsible for:

• Attention control

• Working memory

• Impulse regulation

This action results in:

• Decreased hyperarousal

• Reduced norepinephrine release

• Better behavioral inhibition and focus

Because of its action in the central nervous system (CNS), guanfacine also reduces sympathetic nervous system activity, leading to calming and sedative effects.

💊 Dosage and Administration

• Starting dose: 1 mg once daily, usually at bedtime to minimize daytime sedation

• Usual therapeutic range: 1 mg to 4 mg per day

• Titration: Increased by 1 mg/week if needed

• Form: Extended-release tablet (do not crush, chew, or split)

Note: Not interchangeable with immediate-release guanfacine used for hypertension.

🕒 Onset and Duration

• Onset of effect: 1–2 weeks for initial improvements; full benefits in 4–6 weeks

• Half-life: ~17 hours

• Duration of effect: 24 hours (due to extended-release formulation)

⚠️ Side Effects

Common:

• Drowsiness or sedation

• Fatigue

• Headache

• Abdominal pain

• Dry mouth

• Irritability

Less Common but Serious:

• Hypotension (low blood pressure)

• Bradycardia (slow heart rate)

• Fainting or dizziness (especially with sudden standing)

• Rebound hypertension (if stopped abruptly)

• Depression or mood changes (rare)

🔍 Monitoring Parameters

• Blood pressure and heart rate (especially during titration)

• Behavioral response and functioning

• Sedation levels

• Liver function (in rare cases of hepatic metabolism issues)

🚫 Contraindications and Cautions

Avoid or use with caution in:

• Patients with hypotension, bradycardia, or heart block

• Severe hepatic impairment

• Use of antihypertensives, sedatives, or alcohol (may enhance sedation)

• Children under 6 years (not studied or approved)

• Avoid abrupt discontinuation—must taper slowly

🤝 Drug Interactions

• CNS depressants (e.g., benzodiazepines, alcohol): increased sedation

• CYP3A4 inhibitors (e.g., ketoconazole, grapefruit juice): may increase guanfacine levels

• CYP3A4 inducers (e.g., rifampin): may decrease guanfacine levels

• Antihypertensives: additive hypotensive effects

🌙 Why It’s Often Taken at Night

• Due to its sedative properties, night dosing:

  • Reduces daytime fatigue

  • Enhances sleep onset and quality

  • Is preferred in children with evening hyperactivity

🧒 Use in Children

• Approved for ADHD in ages 6–17

• Well tolerated with appropriate dosing and monitoring

• Can be used alone or in combination with stimulant therapy

• Especially useful in children with:

  • Oppositional behavior

  • Sleep issues

  • Anxiety or emotional dysregulation

🧾 Comparison to Other ADHD Medications

✅ Benefits

• Non-stimulant, low abuse potential

• Improves sleep, impulsivity, and emotional control

• Safe in children with tic disorders

• Useful in children who don’t respond to or tolerate stimulants

❓ Frequently Asked Questions

Is 1 mg enough?

• Yes, for some. Many patients respond well to 1 mg, especially during the early treatment phase.

Is it habit-forming?

• No, it has no abuse or dependence potential.

Can it be used long-term?

• Yes. Long-term studies show stable efficacy and tolerability, especially in pediatric ADHD.

Does it help with anxiety?

• Yes, especially in children with generalized anxiety or agitation.

📦 Storage and Handling

• Store at 25°C (77°F).

• Protect from moisture and light.

• Keep out of reach of children.

Guanfacine ER 1mg is a versatile and well-tolerated non-stimulant ADHD medication. Its calming and sedative effects make it particularly helpful in children with sleep disturbances, impulsivity, emotional dysregulation, and co-occurring anxiety or tics. While not fast-acting, it builds efficacy over time and is often part of a comprehensive behavioral treatment plan.

Guanfacine ER 1mg – Uses, Side Effects, and More

✅ What is Guanfacine ER 1 mg Used For?

Guanfacine ER (brand name Intuniv) is primarily used to treat:

• Attention-Deficit Hyperactivity Disorder (ADHD) in children and adolescents aged 6–17 years.

• Sometimes prescribed off-label for tic disorders, anxiety, post-traumatic stress disorder (PTSD), autism-related aggression, and insomnia.

It works by modulating receptors in the brain (alpha-2A adrenergic receptors), helping to improve attention, reduce hyperactivity, and control impulsivity.

⚖️ Is 1 mg of Guanfacine Enough?

• Depends on the individual.
  1 mg is often a starting dose, especially in children.

• The effective dose typically ranges from 1 mg to 4 mg once daily.

• Dosage is adjusted gradually based on therapeutic response and tolerability.

🧒 Is Guanfacine Safe for Kids?

Yes, Guanfacine ER is FDA-approved for children aged 6–17 years with ADHD.
It’s considered safe when used as prescribed, though monitoring is essential due to:

• Risk of low blood pressure, drowsiness, or slowed heart rate.

• Should not be stopped abruptly due to risk of rebound hypertension.

🌙 Why Take Guanfacine at Night?

• It often causes drowsiness or sedation, so night dosing reduces daytime sleepiness.

• Helps children with ADHD-related insomnia or hyperactivity at bedtime.

• However, timing may vary depending on daytime functioning and therapeutic goals.

😴 Is Guanfacine a Sleeping Pill?

No, but it has sedative properties and is often used off-label for sleep disturbances, especially in neurodivergent children (e.g., autism, ADHD).

🕒 How Does Extended Release Work?

Guanfacine ER tablets release the drug slowly over 24 hours, maintaining a steady blood level. This:

• Reduces the need for multiple daily dosing.

• Minimizes fluctuations in side effects and therapeutic effect.

• Is not interchangeable with guanfacine immediate-release (IR) tablets (used for high blood pressure).

💡 What Are the Positive Effects of Guanfacine?

• Improved attention and impulse control.

• Reduced hyperactivity.

• Calmer behavior and better emotional regulation.

• In some, improved sleep quality and anxiety reduction.

💤 Does Guanfacine Improve Sleep Quality?

Yes, especially in children with:

• ADHD-related insomnia.

• Anxiety-related sleep onset delay.

• Autism spectrum disorders.
  It reduces sleep latency and nighttime awakenings in many patients.

⚖️ Is Guanfacine a Mood Stabilizer?

Not traditionally.
It is not classified as a mood stabilizer like lithium or valproate, but it may help regulate mood indirectly by:

• Reducing emotional reactivity.

• Improving executive function and frustration tolerance.

⏱️ Does Guanfacine Work Immediately?

• No, it doesn’t provide immediate relief like stimulants.

• It may take 1–2 weeks or more to notice behavioral improvement.

• Full effect may be seen after 4–6 weeks.

🧠 What Is the Safest Drug for ADHD?

There’s no single “safest” option, but non-stimulants like Guanfacine are:

• Preferred for children who can’t tolerate stimulants.

• Have cardiac issues, tic disorders, or anxiety.

Other options include:

• Atomoxetine (Strattera)

• Clonidine ER

• Bupropion (off-label)

😟 Is Guanfacine Good for Anxiety?

Yes, guanfacine can help with generalized anxiety, especially in children.
It reduces noradrenaline activity, leading to:

• Less physiological hyperarousal.

• Calmer demeanor and less worry.

🔍 How to Tell if Guanfacine Is Working?

You may notice:

• Reduced fidgeting, interrupting, and impulsiveness.

• Improved bedtime routine and sleep onset.

• Better emotional regulation and tolerance to frustration.

🕰️ Is Guanfacine Safe Long-Term?

Yes, when monitored by a healthcare provider.

• Long-term studies support safety and efficacy for ADHD.

• Key monitoring includes blood pressure, heart rate, growth, and behavioral changes.

❌ Is Guanfacine a Beta Blocker?

No.
Guanfacine is a centrally acting alpha-2 adrenergic agonist, not a beta-blocker.
It works on the central nervous system, not the heart directly like beta-blockers do.

😞 Is Guanfacine an Antidepressant?

No, it’s not classified as an antidepressant.
However, it may improve mood regulation and anxiety, especially in children with ADHD.

🧒 What Is the Best Therapy for Anxiety in Children?

• Cognitive Behavioral Therapy (CBT) is the gold standard.

• May be combined with:

  • Parent training

  • Mindfulness techniques

  • Medications like SSRIs or Guanfacine (off-label)

🧼 Can Guanfacine Treat OCD?

Not directly.

• SSRIs (e.g., fluoxetine, sertraline) are first-line for OCD.

• Guanfacine may help if OCD is co-occurring with ADHD or tics, by improving impulse control.

🧠 Does Guanfacine Improve Memory?

There is some evidence it improves working memory and executive function, particularly in ADHD.
Not a cognitive enhancer in the general population.

😪 Does Guanfacine Make You Sleepy?

Yes. Common side effect.

• Drowsiness is often dose-related.

• May decrease over time as the body adjusts.

🚫 Who Should Not Take Guanfacine?

Avoid or use cautiously in:

• People with low blood pressure or heart problems.

• Those taking other sedatives or blood pressure meds.

• Patients with a history of severe liver disease.

🌙 Is It OK to Take Guanfacine at Night?

Yes, and it’s often recommended due to:

• Drowsiness.

• Better coverage for nighttime symptoms.

• Improved sleep routines.

💧 Is Guanfacine Safe for Kidneys?

Generally yes, but in patients with renal impairment, dose adjustments may be needed.

• It is primarily metabolized by the liver, with some kidney excretion.

🧬 Can Guanfacine Cause Hair Loss?

Hair loss is not a common side effect.

• If it occurs, it may be indirect (due to stress, sleep, nutrition, or other meds).

• Always report unexpected side effects to your provider.

Guanfacine ER 1mg is a non-stimulant ADHD medication with additional benefits for sleep, anxiety, and behavioral regulation, especially in children. It works gradually and must be monitored carefully for blood pressure, sedation, and emotional effects, but it’s considered safe and effective in the long term.

Taj Pharma is an established Indian generics/formulations company, operating from Gujarat (Sarigam/GIDC, Valsad region) and Mumbai headquarters. It states that its manufacturing facility is WHO-GMP, ISO 9001:2018, PIC/S approved and in the process of EU-GMP compliance. Their facility claims monthly capacities of up to 120 million tablets and 40 million capsules, plus granules, effervescent tablets, oral jellies etc. The company emphasises export markets (Africa, Middle-East, LATAM, CIS) alongside domestic supply.

Manufacturer / Supplier / Exporter Role for Guanfacine ER 1 mg

As a manufacturer-supplier-exporter, Taj Pharma would cover the following roles for Guanfacine ER 1 mg:

• Production of finished formulation (extended-release tablet) — subject to formulation development, stability studies, regulatory dossiers.

• Packaging, labelling, blistering/strip or bottle, final finished product for sale or export.

• Supply chain management: domestic distribution in India and export to international markets (upon registration/approval in target countries).

• Export registration support: Taj’s infrastructure supports export markets and international regulatory compliance (WHO-GMP, PIC/S).

• Partnering with overseas distributors/agents, handling logistics, compliance with importation requirements in destination countries.

For a product such as Guanfacine ER 1 mg (non-stimulant ADHD therapy), Taj Pharma’s capability to manufacture high-volume tablets and export to emerging markets aligns well with demand from markets such as the Philippines, Middle East, Africa.

Key Selling/Competitive Points

• Large production capacity: enabling economies of scale, competitive pricing.

• International certifications: WHO-GMP, PIC/S recognised- which helps in export regulatory acceptability.

• Export-ready: Taj expressly markets itself as export manufacturer for LATAM, Africa, Middle-East.

• Full range of dosage forms and ability to customise packaging/blistering for export markets.

• Established global footprint: offers assurance for buyers/distributors in multiple geographies.

Key Considerations / Buyer-Tips

• Ensure that the Guanfacine ER formulation is developed, validated and bioequivalent (if required) for export markets.

• Verify licensure and registration in target export destination (e.g., Philippines MOH, GCC regulatory body) for Guanfacine ER product.

• Confirm packaging requirements (language, blister vs bottle, shelf-life) for the destination market and that Taj Pharma meets those.

• Inspect regulatory certifications (WHO-GMP certificate copy, audit reports) for the specific manufacturing site producing the ER tablet.

• Ask for stability data, certificate of analysis, batch-release documentation, and country-specific required filings (e.g., CEP, DMF).

• Clarify supply-chain lead-times, minimum order quantities, export pricing terms (FOB, CIF), logistic partner, customs clearance experience.

Taj Pharma India Ltd. presents itself as a capable manufacturer, supplier and exporter of formulated generic tablets – and in this context would serve as a qualified partner for bringing Guanfacine Extended-Release (ER) Tablets 1 mg to both domestic and export markets. Their manufacturing scale, certification profile, and export orientation are strong advantages. For a buyer or partner interested in Guanfacine ER 1 mg, aligning with Taj Pharma could offer cost-effective supply with global reach — provided the regulatory, formulation development and marketing registration aspects are properly addressed.