Lithium Carbonate Sustained Release Tablets USP 400mg India

Lithium Carbonate Sustained Release Tablets USP 400mg Technical Specification:

Product Name:	Lithium Carbonate Sustained Release Tablets USP 400mg
Brand Name:	Generic
Strength:	300mg, 400mg
Dosage Form:	Tablets (Film-coated)
Route of Administration:	Via Oral Route
Packing:	2s, 10s, 30s, 100s
Pack Insert/Leaflet:	PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:	COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:	Antidepressants, Central nervous system
Indication:	Lithium Carbonate is used to treat manic-depressive disorder (bipolar disorder).
Storage:	Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

GENERIC NAME OF THE MEDICINAL PRODUCT:

Lithium Carbonate Sustained Release Tablets USP 400mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Lithium Carbonate Sustained Release Tablets USP 400mg
Each sustained release tablet contains:
Lithium Carbonate USP…………………400mg
Excipients………………………………………q.s.

THERAPEUTIC INDICATIONS:

Lithium Carbonate is used to treat manic-depressive disorder (bipolar disorder). It works to stabilize the mood and reduce extremes in behavior by restoring the balance of certain natural substances (neurotransmitters) in the brain.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH

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

STORAGE & DOSAGE:

Storage: Store the unit-dose blister pack in this bottle with the cap tightly secured till both tablets have been consumed.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Dosage: As directed by the Physician

Why Taj Pharmaceuticals?

Taj Pharmaceuticals stands out as a reliable and patient-focused provider of Lithium Carbonate SR Tablets for several compelling reasons. First and foremost, they prioritize quality assurance, ensuring that every tablet meets rigorous standards for efficacy and safety. This commitment to quality extends to their reliable supply chain, assuring individuals with mood disorders such as bipolar disorder that their medication will be consistently available when needed. Affordability is another hallmark of Taj Pharmaceuticals’ approach, recognizing the importance of making essential medications like Lithium Carbonate SR Tablets accessible to patients on long-term treatment regimens. With years of experience and expertise in the pharmaceutical industry, Taj Pharmaceuticals has earned a reputation for producing effective medications and maintaining a patient-centered approach that focuses on improving the well-being of those in need. Additionally, their adherence to regulatory standards and commitment to compliance instills confidence in healthcare providers and patients alike. Taj Pharmaceuticals’ dedication to offering support and educational resources further enhances the overall patient experience, helping individuals better understand their treatment options and related conditions. While these reasons make Taj Pharmaceuticals a compelling choice, the ultimate decision regarding medication should always be made in consultation with a qualified healthcare professional who can tailor treatment to the specific needs and medical history of the patient.

What is Lithium Carbonate SR Tablets and its uses:

Lithium Carbonate SR (Sustained-Release) Tablets are a medication commonly prescribed to manage certain mood disorders, primarily bipolar disorder. Here’s an overview of what Lithium Carbonate SR Tablets are and their uses:

Lithium Carbonate SR Tablets:

Lithium Carbonate is a compound that contains lithium, an element known for its mood stabilizing properties. The “SR” in Lithium Carbonate SR Tablets stands for “sustained release,” which means that the medication is designed to release lithium slowly into the bloodstream over an extended period. This allows for more stable blood levels of lithium and reduces the frequency of dosing compared to immediate release forms of lithium.

Uses:

Bipolar Disorder: The primary and most well-known use of Lithium Carbonate SR Tablets is in the treatment of bipolar disorder, a mental health condition characterized by extreme mood swings, including manic (elevated mood, hyperactivity) and depressive (low mood, lack of energy) episodes. Lithium helps stabilize mood, reducing the frequency and severity of manic and depressive episodes. It is particularly effective in managing bipolar disorder’s manic phase.
Preventing Recurrence: In addition to managing acute manic episodes, Lithium Carbonate SR Tablets are often prescribed for long-term maintenance therapy to prevent the recurrence of manic and depressive episodes in individuals with bipolar disorder. It helps to maintain emotional stability and reduce the risk of relapse.
Augmentation Therapy: In some cases, Lithium Carbonate SR may be prescribed alongside other medications as augmentation therapy for individuals who do not respond adequately to other mood stabilizers or antidepressants. This combination approach can enhance treatment effectiveness.
Schizoaffective Disorder: Lithium may also be used in the treatment of schizoaffective disorder, a condition characterized by a combination of mood disorder symptoms (similar to bipolar disorder) and schizophrenia like symptoms (such as hallucinations or delusions).

It’s important to note that the use of Lithium Carbonate SR Tablets requires careful monitoring by a qualified healthcare provider. Dosage adjustments are often necessary to achieve therapeutic blood levels while minimizing potential side effects. Monitoring lithium levels in the blood is essential because maintaining the correct level is crucial for its effectiveness and safety. Additionally, individuals taking lithium should adhere to their healthcare provider’s recommendations and regularly attend follow-up appointments to assess their progress and address any side effects or concerns. Lithium treatment is not suitable for everyone, and its use should be determined on a case-by-case basis by a healthcare professional.

How Does Lithium Carbonate SR Tablets Work?

Lithium Carbonate SR (Sustained-Release) Tablets work by influencing various neurochemical processes in the brain to help stabilize mood. While the exact mechanism of lithium’s action isn’t fully understood, it is believed to have several effects that contribute to its mood-stabilizing properties:

Neurotransmitter Balance: Lithium is thought to help balance the levels of certain neurotransmitters in the brain, including serotonin and norepinephrine. These neurotransmitters play crucial roles in regulating mood, and their dysregulation is associated with mood disorders like bipolar disorder.
Neuroprotective Effects: Lithium may have neuroprotective properties, helping to protect brain cells from damage and promoting their survival. This neuroprotection may contribute to the long-term stabilization of mood.
GABA Enhancement: Lithium can enhance the activity of gamma-aminobutyric acid (GABA), which is an inhibitory neurotransmitter. By increasing GABA’s inhibitory effects, lithium may help reduce the excessive excitability of neurons that can occur during manic episodes in bipolar disorder.
Inhibition of Cyclic AMP (cAMP): Lithium can decrease the activity of cyclic AMP, a signalling molecule in brain cells. Abnormalities in cAMP signalling have been linked to mood disorders, and lithium’s inhibition of cAMP may contribute to its mood-stabilizing effects.
Altering Ionic Balance: Lithium ions can replace other ions in nerve cells, affecting the cell’s electrical activity and signalling. This alteration of ionic balance can influence neurotransmitter release and neuronal excitability.
Cellular and Genetic Effects: Lithium can also impact various cellular and genetic processes involved in mood regulation, including gene expression and the function of specific proteins.

It’s important to note that the therapeutic range of lithium in the bloodstream is relatively narrow. Maintaining the correct blood level of lithium is essential for its mood-stabilizing effects while minimizing potential side effects. Regular blood tests are necessary to monitor lithium levels, and dosage adjustments may be required based on individual response and tolerance.

The precise way lithium exerts its mood-stabilizing effects likely involves a combination of these mechanisms. Because lithium treatment requires careful monitoring and dosage adjustments, it should only be used under the supervision of a qualified healthcare provider who can assess the patient’s specific needs and response to the medication.

Benefits of Lithium Carbonate SR (Sustained-Release) Tablets:

Mood Stabilization: The primary benefit of Lithium Carbonate SR Tablets is their effectiveness in stabilizing mood. They are a cornerstone in the treatment of bipolar disorder, helping to reduce the frequency and severity of manic and depressive episodes.
Long-Term Maintenance: Lithium is often used for long-term maintenance therapy to prevent the recurrence of mood episodes in individuals with bipolar disorder. This can significantly improve the individual’s quality of life and reduce the risk of relapse.
Reduced Suicidal Risk: Studies have suggested that lithium treatment may reduce the risk of suicide in individuals with mood disorders, particularly bipolar disorder. It can help manage impulsive behavior and suicidal thoughts associated with the condition.
Augmentation Therapy: Lithium Carbonate SR Tablets can be used in combination with other medications to enhance the effectiveness of treatment, especially when individuals do not respond adequately to other mood stabilizers or antidepressants.
Schizoaffective Disorder: Lithium may also be beneficial for individuals with schizo-affective disorder, helping to manage both mood and psychotic symptoms.

Side Effects of Lithium Carbonate SR Tablets:

It’s important to note that while lithium can be highly effective, it can also cause a range of side effects, some of which can be serious. Common side effects include:

Thirst and Increased Urination: Polyuria (excessive urination) and polydipsia (increased thirst) are common side effects of lithium. These can often be managed by staying hydrated.
Hand Tremors: Many individuals on lithium experience fine hand tremors, which can be bothersome but are usually not harmful.
Weight Gain: Some people may experience weight gain while taking lithium, which can be challenging for those trying to manage their weight.
Digestive Issues: Gastrointestinal problems like nausea, diarrhea, or stomach discomfort can occur with lithium use.
Kidney Function: Long-term lithium use may affect kidney function in some individuals. Regular monitoring of kidney function is essential.
Hypothyroidism: Lithium can disrupt thyroid function in some people, leading to hypothyroidism (underactive thyroid). Regular thyroid function tests are necessary.
Increased Lithium Levels: Accidental or intentional overdose of lithium can lead to toxicity, which can be life-threatening. Symptoms of lithium toxicity include confusion, tremors, seizures, and potentially cardiac complications.
Neurological and Cognitive Effects: Lithium may cause cognitive and memory problems in some individuals, although these effects are generally reversible upon discontinuation.
Skin Reactions: Lithium can sometimes cause skin reactions like acne or psoriasis.
Interactions: Lithium can interact with other medications, supplements, and certain medical conditions, so it’s essential to inform your healthcare provider of all the medications you are taking.

It’s crucial for individuals taking Lithium Carbonate SR Tablets to have regular follow-up appointments with their healthcare provider for ongoing monitoring of lithium levels and assessment of side effects. Lithium treatment requires careful management to balance its benefits against potential side effects, and any concerns or adverse reactions should be promptly discussed with a healthcare professional.

Frequently Asked Questions About Lithium Carbonate SR Tablets:

Certainly, here are some frequently asked questions (FAQs) about Lithium Carbonate SR (Sustained Release) Tablets:

What is Lithium Carbonate SR Tablets used for?

Lithium Carbonate SR Tablets are primarily used to stabilize mood in individuals with bipolar disorder, reducing the frequency and severity of manic and depressive episodes.

How does Lithium Carbonate SR work in bipolar disorder treatment?

Lithium is believed to influence neurotransmitters and various neurochemical processes in the brain, helping to stabilize mood and reduce mood swings associated with bipolar disorder.

What is the difference between Lithium Carbonate SR and immediate release Lithium Carbonate?

Lithium Carbonate SR (sustained release) tablets release lithium into the bloodstream slowly over an extended period, reducing the number of daily doses required compared to immediate release forms of lithium.

How long does it take for Lithium Carbonate SR Tablets to start working?

The onset of action can vary from person to person, but it may take several days to a few weeks for individuals to experience the full mood stabilizing effects. It’s important to continue taking the medication as prescribed.

What is the recommended dosage of Lithium Carbonate SR Tablets?

The dosage is individualized based on the patient’s specific needs, medical history, and lithium blood levels. Healthcare providers carefully adjust the dose to achieve therapeutic levels while minimizing side effects.

What are the common side effects of Lithium Carbonate SR Tablets?

Common side effects include increased thirst, excessive urination, hand tremors, weight gain, gastrointestinal issues, and potential cognitive effects. Regular monitoring and reporting of side effects are essential during treatment.

Can Lithium Carbonate SR Tablets be taken during pregnancy or while breastfeeding?

The use of lithium during pregnancy and breastfeeding should be carefully considered and monitored by a healthcare provider. It’s important to weigh the potential benefits against the potential risks.

Are there dietary restrictions while taking Lithium Carbonate SR Tablets?

Maintaining stable sodium levels is important while taking lithium, so it’s advisable to maintain a consistent and moderate sodium intake. Changes in diet, especially excessive sodium intake, can affect lithium levels in the bloodstream.

Can Lithium Carbonate SR Tablets interact with other medications?

Yes, lithium can interact with various medications and supplements, so it’s crucial to inform your healthcare provider of all the medications you are taking to prevent potential interactions.

What should I do if I miss a dose of Lithium Carbonate SR Tablets?

If you miss a dose, take it as soon as you remember. However, if it’s close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not double the dose to make up for a missed one.

How often should I have my lithium blood levels monitored?

The frequency of blood level monitoring varies but is typically done every few months to ensure therapeutic levels and monitor for potential side effects or toxicity.

Individuals considering or currently taking Lithium Carbonate SR Tablets should consult with their healthcare provider to address any questions or concerns specific to their treatment and medical history.

As Lithium Carbonate SR Tablets Exporters; We can cater to export business queries from the following geographies. We are exporting our Lithium Carbonate SR Tablets product in the Following Countries-

Russia and CIS Countries: Azerbaijan, Armenia, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Russia, Tajikistan, Turkmenistan, Uzbekistan and Ukraine

GCC/ Middle East Countries: Saudi Arabia, Yemen, Oman, Bahrain, UAE, Lebanon, Jordan, and Iraq.

African Countries: Nigeria, Tanzania, Sudan, Zambia, Benin, Angola, Liberia

Southeast Asia: Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, Vietnam, Brunei Darussalam

Other Asian Countries: Nepal, Myanmar, Malaysia, Cambodia, Bhutan, Sri Lanka, Mauritius

Lithium Carbonate SR Tablets Regulatory Documents:

Certificate of Analysis (COA)
Method of Analysis (MOA)
Stability Data (Accelerated stability / Long-term stability / Zone 4b)
CTD Dossier / ACTD Dossiers / eCTD Dossiers
Certificate of Pharmaceuticals Product (COPP)
Free Sale Certificate (FSC)

Contact the most reliable manufacturer of Lithium Carbonate SR Tablets, Taj Pharmaceuticals Limited, to get bulk quantities at a reasonable price.

To Place Orders:

Direct line: +91 8448 444 095 / WhatsApp +91 74 0000 9975 / 74 0000 9976
E-Mail: info@tajpharma.com
Toll free: 1-800-222-434 / Toll free: 1-800-222-825
General EPA BX: +91 22 2637 4592 / +91 22 2637 4593
Fax No: +91 22 2634 1274

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Lithium Carbonate Sustained Release Tablets USP 400mg