Phentolamine mesylate injection BP 5mg/ml Technical Specification:
Product Name: | Phentolamine mesylate injection BP |
Brand Name: | Pegitor |
Strength: | 5mg/ml, 10mg/ml |
Dosage Form: | Dry Powder Injection (Sterile) |
Packing: | LYOPHILIZED Powder |
Route of Administration: | FOR IM OR IV USE |
Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
Therapeutic use: | Antihypertensives, Antidotes, Alpha Blockers |
Indication: | Phentolamine may also be used to reverse the effects of an anesthetic medicine in soft tissues, such as the lips and tongue. |
Storage: | Store Protected from moisture at a temperature not exceeding 30°C |
GENERIC NAME OF MEDICINAL PRODUCT:
- Phentolamine mesylate injection BP 10mg/ml
- Phentolamine mesylate injection BP 5mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1.Phentolamine mesylate injection BP 10mg/ml
Each ml contains:
Phentolamine mesylate BP………………10mg
Benzyl alcohol USP……………………………1%w/v
2.Phentolamine mesylate injection BP 5mg/ml
Each ml contains:
Phentolamine mesylate BP………………5mg
Benzyl alcohol USP……………………………0.5%w/v
THERAPEUTIC INDICATION:
Phentolamine Mesylate for Injection is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine.
CAUTION & Warning:
CAUTION: It is Dangerous to take this preparation Except in accordance with the medical advice.
Warning: Not to be sold by retail without the prescription of registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store Protected from moisture at a temperature not exceeding 30°C
Keep medicine out of reach of children.
The Injection should be discarded if any particles Appear.
Dosage: As directed by Physician.
Why Taj Pharmaceuticals?
Taj Pharmaceuticals is a preferred choice for Phentolamine Mesylate Injection due to several notable reasons. First and foremost, the company is renowned for its unwavering commitment to maintaining the highest standards of quality in pharmaceutical production. Quality is a critical factor when it comes to medications like Phentolamine Mesylate Injection, which are utilized in various medical scenarios, including hypertensive emergencies and specific surgical procedures. Taj Pharmaceuticals’ dedication to quality assurance instills confidence among healthcare providers and patients, ensuring the effectiveness and safety of the medication. With years of experience in the pharmaceutical industry, Taj Pharmaceuticals has accumulated valuable expertise in the manufacturing and delivery of effective medications. Their track record of consistently producing high-quality pharmaceuticals has solidified their reputation as a trusted supplier. In situations where precise dosing and reliable efficacy are paramount, such as when using Phentolamine Mesylate Injection, this experience becomes particularly valuable.
Furthermore, a reliable supply chain is crucial, especially for medications used in emergency situations or critical medical procedures. Phentolamine Mesylate Injection may be needed promptly to manage hypertensive crises or during specific surgical interventions. Taj Pharmaceuticals’ commitment to maintaining a dependable supply chain ensures that healthcare institutions and patients have uninterrupted access to this vital medication. Taj Pharmaceuticals places a strong emphasis on patient well-being and safety. This aligns seamlessly with the goal of providing medications like Phentolamine Mesylate Injection, which are employed in scenarios that demand careful patient monitoring and safety precautions. The company’s patient-centered approach ensures that healthcare providers and patients can trust the medication’s efficacy and safety. Affordability is also a key consideration, as access to essential medications should not be hindered by prohibitive costs. Taj Pharmaceuticals may offer competitive pricing options, making medications like Phentolamine Mesylate Injection more accessible to healthcare institutions and patients, ultimately enhancing the overall quality of care. In addition to these attributes, Taj Pharmaceuticals diligently adheres to strict regulatory standards to ensure the safety and efficacy of their pharmaceutical products. This commitment to compliance provides healthcare providers and patients with the assurance that the medication meets the highest standards of quality and safety.
Educational resources and support are crucial components of effective medication management, particularly when medications like Phentolamine Mesylate are used in complex medical procedures or emergencies. Taj Pharmaceuticals may offer valuable information and support to healthcare providers, contributing to improved treatment outcomes and patient care. Lastly, Taj Pharmaceuticals’ global presence and distribution network further facilitate the availability of medications in various regions, ensuring that they reach healthcare providers and patients worldwide. This extensive reach enhances the accessibility and availability of critical medications, strengthening healthcare systems on a global scale. In conclusion, Taj Pharmaceuticals’ commitment to quality, reliability, affordability, compliance, patient support, and global outreach makes it a compelling choice for healthcare providers seeking a trusted supplier for Phentolamine Mesylate Injection and other pharmaceutical needs. Their dedication to patient safety aligns seamlessly with the importance of this medication in effectively managing medical conditions and emergencies.
What is Phentolamine Mesylate Injection and its uses?
Phentolamine Mesylate Injection is a medication that contains the active ingredient phentolamine mesylate. It is used for specific medical purposes and has several important uses:
- Hypertensive Emergencies: Phentolamine Mesylate Injection is commonly used in hypertensive emergencies, which are situations where a person’s blood pressure becomes dangerously high and requires immediate treatment. Examples of hypertensive emergencies include hypertensive crises, pheochromocytoma crisis, and malignant hypertension. Phentolamine is used to rapidly lower blood pressure in these critical situations.
- Reversal of Local Anesthesia: Phentolamine Mesylate can be used to reverse the effects of local anesthesia in dental and surgical procedures. It helps to reduce the duration of numbness and restore normal sensation to the affected area.
- Diagnosis and Treatment of Pheochromocytoma: Pheochromocytoma is a rare tumor of the adrenal gland that can lead to severe hypertension. Phentolamine Mesylate is sometimes used as part of a diagnostic test to confirm the presence of pheochromocytoma and, in some cases, to manage the symptoms associated with this condition.
- Extravasation of Vasoactive Drugs: In healthcare settings, particularly during intravenous (IV) administration of vasoactive drugs (drugs that affect blood vessels), there is a risk of these drugs leaking into surrounding tissues (extravasation). Phentolamine Mesylate can be used to counteract the vasoconstrictive effects of certain drugs and minimize tissue damage in cases of extravasation.
- Raynaud’s Phenomenon: In some cases, Phentolamine Mesylate may be considered for the management of Raynaud’s phenomenon, a condition characterized by extreme sensitivity to cold temperatures, leading to blood vessel spasms in the fingers and toes.
It’s important to note that Phentolamine Mesylate Injection should be administered under the supervision and guidance of a qualified healthcare professional, as it is a potent medication with potential side effects. The dosage and administration depend on the specific medical condition being treated and the patient’s individual response to the medication.
How Does Phentolamine Mesylate Injection Work?
Phentolamine Mesylate Injection works as an alpha-adrenergic antagonist, meaning it blocks the effects of certain neurotransmitters known as norepinephrine and epinephrine (also called adrenaline) at alpha-adrenergic receptors. Here’s how Phentolamine Mesylate works:
- Alpha-Adrenergic Receptors: The body has different types of adrenergic receptors, including alpha and beta receptors, which respond to the neurotransmitter’s norepinephrine and epinephrine. Alpha-adrenergic receptors are found in various tissues, including blood vessels.
- Norepinephrine and Epinephrine: Norepinephrine and epinephrine are chemicals that the body releases in response to stress or other triggers. They bind to alpha-adrenergic receptors in blood vessels, causing these vessels to constrict or narrow. This constriction leads to an increase in blood pressure.
- Phentolamine Mesylate Blockade: When Phentolamine Mesylate is injected, it competes with norepinephrine and epinephrine for binding to alpha-adrenergic receptors. Phentolamine Mesylate acts as an antagonist, which means it binds to these receptors without activating them.
- Vasodilation: By binding to alpha-adrenergic receptors without activating them, Phentolamine Mesylate prevents norepinephrine and epinephrine from causing blood vessels to constrict. This results in vasodilation, which is the widening of blood vessels. As the blood vessels dilate, they allow more blood to flow through them, reducing resistance to blood flow and subsequently lowering blood pressure.
In summary, Phentolamine Mesylate Injection counteracts the effects of norepinephrine and epinephrine by blocking their action at alpha-adrenergic receptors. This leads to vasodilation and a decrease in blood pressure, making it useful in the treatment of hypertensive emergencies and other medical situations where rapid blood pressure reduction is required. Additionally, it can be used to reverse the vasoconstrictive effects of certain medications or treat specific medical conditions as directed by a healthcare professional.
Benefits of Phentolamine Mesylate Injection:
- Rapid Blood Pressure Reduction: Phentolamine Mesylate is a potent medication that can rapidly lower blood pressure. This makes it valuable in emergency situations, such as hypertensive crises, where immediate blood pressure control is essential to prevent organ damage or complications.
- Effective Reversal of Local Anesthesia: In dental and surgical procedures where local anesthesia is administered, Phentolamine Mesylate can be used to reverse the anesthetic effects quickly. This helps patients regain sensation in the affected area, facilitating post-procedure recovery.
- Treatment of Pheochromocytoma Crisis: Phentolamine Mesylate is employed in the management of pheochromocytoma crises, a rare condition characterized by severe hypertension caused by adrenal gland tumors. By reducing blood pressure and alleviating symptoms, it aids in stabilizing patients with this condition.
- Extravasation Management: In healthcare settings, particularly during intravenous drug administration, there is a risk of drugs leaking into surrounding tissues (extravasation). Phentolamine Mesylate is used to counteract the vasoconstrictive effects of certain drugs, helping to minimize tissue damage and discomfort in such cases.
- Versatile Medication: Phentolamine Mesylate’s versatility makes it a valuable tool in various medical scenarios. Its ability to rapidly lower blood pressure and reverse the effects of local anesthesia makes it indispensable in emergency medicine and surgical settings.
It’s important to note that the use of Phentolamine Mesylate Injection should be carefully considered and administered by healthcare professionals, as it is a potent medication with potential side effects. The benefits of using Phentolamine Mesylate are most pronounced when its administration aligns with the specific medical condition being treated, ensuring optimal patient care and safety.
Side Effects of Phentolamine Mesylate Injection:
- Hypotension: The most common side effect of Phentolamine Mesylate is low blood pressure (hypotension). While this is the intended effect when treating hypertensive emergencies, excessive lowering of blood pressure can lead to dizziness, fainting, and other symptoms.
- Tachycardia: In response to a sudden drop in blood pressure, the body may react by increasing the heart rate (tachycardia) to maintain adequate blood flow to vital organs. This can lead to palpitations and a racing heart.
- 3. Flushing: Some individuals may experience flushing, which is characterized by a sudden and temporary redness of the skin. This is due to the dilation of blood vessels.
- Nausea and Vomiting: Gastrointestinal symptoms, such as nausea and vomiting, can occur as a side effect of Phentolamine Mesylate.
- Orthostatic Hypotension: Phentolamine can cause orthostatic hypotension, where blood pressure drops significantly when transitioning from lying down to standing up. This can result in dizziness or fainting upon standing.
- Allergic Reactions: While rare, allergic reactions to Phentolamine Mesylate can occur and may manifest as skin rash, itching, swelling, or more severe allergic responses. Immediate medical attention is necessary if a severe allergic reaction occurs.
- Arrhythmias: In some cases, Phentolamine Mesylate may lead to irregular heart rhythms (arrhythmias). This is more likely to occur in individuals with pre-existing heart conditions.
- Other Side Effects: Phentolamine Mesylate can also cause less common side effects, including headache, nervousness, and gastrointestinal discomfort.
It’s crucial to use Phentolamine Mesylate Injection under the supervision of a healthcare professional who can monitor its effects and adjust the dosage as needed. The choice to use this medication is typically based on a careful assessment of the patient’s medical condition and the potential benefits and risks associated with its administration.
Frequently Asked Questions About Phentolamine Mesylate Injection:
Certainly, here are some frequently asked questions (FAQs) about Phentolamine Mesylate Injection:
- What is Phentolamine Mesylate Injection used for?
Phentolamine Mesylate Injection is primarily used for the rapid reduction of blood pressure, making it valuable in hypertensive emergencies. It is also used to reverse the effects of local anesthesia and manage certain medical conditions.
- How does Phentolamine Mesylate Injection lower blood pressure?
Phentolamine Mesylate works by blocking alphaadrenergic receptors, which are involved in regulating blood vessel constriction. By blocking these receptors, it causes blood vessels to dilate, reducing resistance to blood flow and lowering blood pressure.
- When is Phentolamine Mesylate Injection administered during dental procedures?
Phentolamine Mesylate Injection is administered to reverse the effects of local anesthesia after dental procedures. It helps patients regain normal sensation in the treated area more quickly.
- What is a hypertensive crisis, and how is Phentolamine Mesylate used in such emergencies?
A hypertensive crisis is a situation where blood pressure becomes dangerously high, posing a risk to organs and health. Phentolamine Mesylate is used in hypertensive crises to rapidly lower blood pressure and prevent complications.
- Can Phentolamine Mesylate Injection be used to treat high blood pressure (hypertension) on a longterm basis?
Phentolamine Mesylate is generally not used for the longterm treatment of hypertension. It is typically reserved for emergency situations when immediate blood pressure reduction is required.
- Are there any common side effects of Phentolamine Mesylate Injection?
Common side effects may include low blood pressure (hypotension), tachycardia (rapid heartbeat), flushing, and gastrointestinal symptoms like nausea.
- Is Phentolamine Mesylate Injection safe for everyone?
Phentolamine Mesylate should be used under the guidance of a healthcare professional. It may not be suitable for individuals with certain medical conditions or medications that interact with it. Its use should be carefully considered based on individual patient needs.
- What is the dosage and administration of Phentolamine Mesylate Injection?
The dosage and administration of Phentolamine Mesylate Injection depend on the specific medical condition being treated. Healthcare professionals will determine the appropriate dose and route of administration.
- Can Phentolamine Mesylate Injection be used during pregnancy or breastfeeding?
The use of Phentolamine Mesylate during pregnancy or breastfeeding should be carefully considered by healthcare providers, as the benefits and risks must be weighed on a casebycase basis.
- Are there any contraindications or interactions with other medications?
Phentolamine Mesylate may interact with certain medications or medical conditions. Healthcare providers should be aware of potential contraindications and drug interactions when prescribing or administering this medication.
These FAQs provide an overview of Phentolamine Mesylate Injection and its uses. However, individual patient circumstances and healthcare provider guidance should always be taken into consideration when using this medication.
As Phentolamine Mesylate Injection Exporters; We can cater to export business queries from the following geographies. We are exporting our Phentolamine Mesylate Injection 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
Phentolamine Mesylate Injection 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 Phentolamine Mesylate Injection, 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
GENERIC NAME OF MEDICINAL PRODUCT:
a) Phentolamine mesylate injection BP 10mg/ml
b) Phentolamine mesylate injection BP 5mg/ml
b) Phentolamine mesylate injection BP 5mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Phentolamine mesylate injection BP 10mg/ml
Each ml contains:
Phentolamine mesylate BP………………10mg
Benzyl alcohol USP…………………………...1%w/v
2. Phentolamine mesylate injection BP 5mg/ml
Each ml contains:
Phentolamine mesylate BP………………5mg
Benzyl alcohol USP…………………………...0.5%w/v
Each ml contains:
Phentolamine mesylate BP………………10mg
Benzyl alcohol USP…………………………...1%w/v
2. Phentolamine mesylate injection BP 5mg/ml
Each ml contains:
Phentolamine mesylate BP………………5mg
Benzyl alcohol USP…………………………...0.5%w/v
THERAPEUTIC INDICATION:
Phentolamine Mesylate for Injection is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine.
CAUTION & WARNING:
CAUTION: It is Dangerous to take this preparation Except in accordance with the medical advice.
Warning: Not to be sold by retail without the prescription of registered Medical Practitioner.
Warning: Not to be sold by retail without the prescription of registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store Protected from moisture at a temperature not exceeding 30°C
Keep medicine out of reach of children.
The Injection should be discarded if any particles Appear.
Dosage: As directed by Physician
Keep medicine out of reach of children.
The Injection should be discarded if any particles Appear.
Dosage: As directed by Physician