Addyzoa spc 2013


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Addyzoa Summary of Product Characteristics (SPC)

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Addyzoa spc 2013

  1. 1. Addyzoa capsules a) All ingredients present in the formulation: Each capsule contains: Name of Ingredient Latin/ English Name Qty Powders : Purnachandrodaya rasa >>>> 45 mg Muktashukti bhasma Pearl Oyster Shell Calx 30 mg Suvarnamakshik bhasma >>>> 30 mg Shilajit shuddha Purified Asphaltum 30 mg Abhrak bhasma Mica (Calcined) 30 mg Makardhwaj rasa >>>> 15 mg Rasa sindur Mercuric Sulphide 15 mg Dry extract of the following : Puncture Vine Tribulus terrestris 200 mg Ashtavarga >>>> 200 mg Indian Spider Plant Chlorophytum arundinaceum 150 mg Purified Cow-Itch Plant Purified Mucuna pruriens 150 mg Heart Leaved Moonseed Tinospora cordifolia 150 mg Winter Cherry Withania somnifera 150 mg Indian Gooseberry Emblica officinalis 75 mg Country Mallow Sida cordifolia 75 mg Hawaiian Baby Woodrose Argyreia speciosa 75 mg Asparagus Asparagus racemosus 75 mg
  2. 2. Polynesian Arrowroot Tacca aspera 30 mg China Root Smilax china 30 mg Sweet Potato Ipomoea digitata 30 mg Orchid Eulophia campestris 15 mg Besides medicinal plants, a number of Ayurvedic formulations are known to contain inorganic substances like mercury, arsenic, lead, zinc, tin, iron, sulfur and copper. Herbo-metallic Ayurvedic preparations can be bhasma (powder of a substance obtained by calcinations; mainly applied to metals and minerals), rasa-yoga (preparations containing minerals as main ingredients; the minerals may be mica, copper-pyrites, or elements like gold, silver or copper), and rasa aushadhi (preparations containing metals and minerals). Since metals maybe toxic in their native forms, classical Ayurveda describes methods for detoxification of both metals and minerals. Ayurveda explains bhasma as anything organic or inorganic incinerated into its ash (3). These are generally end products of incineration process. The starting material undergoes an elaborate process of purification (shodhana). This process is followed by the reaction phase, which involves incorporation of some other mineral and herbal extracts. Then the material in pellet form is incinerated in a furnace. The end product is expected to be non-toxic material. Traditionally Bhasmas have been indicated for various disorders such as Loha Bhasma (Iron oxide) in anemia, Muktashukti Bhasma (consisting of Pearl, Aloe Vera and Lime juice) as anti inflammatory and Abhrak Bhasma (Mica) as Hepatoprotective. Poorna chandrodayam (Purnachandrodaya rasa or PC) is an elixir of mercury and gold widely used in Siddha Medicine prepared by kupi pudam process. It is a bright scarlet red coloured powder, soluble in Aqua regia. Content of gold, mercury and sulphur were found to be 9.78, 78.11 and 11.95 g, respectively and 280 ppm of free mercury. The studies confirms that PC is converted into an amalgamation process and mostly present as Mercury sulphide along with gold and a small portion of mercury oxide. Aqua regia (lit. "royal water"), aqua regis (lit. "king's water"), or nitro-hydrochloric acid is a highly corrosive mixture of acids, a fuming yellow or red solution. The mixture is formed by freshly mixing concentrated nitric acid and hydrochloric acid,[1] usually in a volume ratio of 1:3. It was named so because it can dissolve the so-called royal or noble metals, gold and platinum. Muktashukti bhasma (MSB) is an Ayurvedic compound, consisting of Purified Pearl Shell (1 part), Aloe Vera Juice (Q.S.) and fresh Lime Juice (Q.S.).
  3. 3. Method of Processing Purified Pearl Oyster Shells are transferred to a vessel half-filled with Aloe Vera juice. Pearl Oyster Shell pieces are placed over the thick juice and the remaining space in the vessel is again covered by adding Aloe Vera juice. The vessel is sealed and given a Gajput (refer glossary). On cooling Pearl Oyster Shell pieces are removed and blended with fresh lime juice in a flat surfaced vessel. The mixture is rolled into a cake and dried. The dried cake is again given a Gajput to obtain soft - butter like Mauktik-Shukti Bhasma (Pearl Oyster Shell Calx). Pearl oyster Calx is then processed in cow's milk or Chandanaadi Ark, dried and stored. Gajput: It is heated in absence of air in 800 – 900 degree Celsius for 2 – 3 hours. This process is repeated for three times, to get white colored Muktasukti Bhasma (Pearl Oyster Calx) Suvarnamakshik bhasma is an Ayurvedic compound, consisting of Purified Copper pyrite (1 part), and fresh Lemon Juice (Q.S.). Shilajit shuddha English name: Asphaltum Traditional Uses: Analysis of Shilajit reveals that it is high in naturally occurring minerals and elements. Shilajit is Mother Nature's original organic Colloidal multi-mineral supplement with self assimilation qualities as compared to inorganic colloidal sources. And yet Shilajit is much more than colloidal minerals. It has unique properties not found in any other natural preparation. There is a folk saying by the indigenous people who live in the Himalayan region that Shilajit makes the body strong as a rock and there some rock-like qualities in Shilajit. There is hardly a disease that cannot be cured or least helped by Shilajit. Shilajit amplifies the benefits of other herbs by enhancing their bio-availability. It helps transport nutrients deep into the tissue and removes deep-seated toxins. Shilajit improves memory and the ability to handle stress. Shilajit reduces recovery time in muscle, bone and nerve injuries. Shilajit stimulates the immune system and reduces chronic fatigue. It is an adaptogen, (Rasayna), that helps to combat immune disorders, urinary tract disorders, nervous disorders and sexual dissatisfaction. Abhraka Bhasma (Purified Mica) is triturated with various herbal water decoctions and juice extracts, made into thin disc shaped cakes, and subjected to 800 – 900 degree Celsius heat. The process is repeated for several times. The end product will be a very fine powder. If it is repeated for 100 times, it is known as Shataputi Abhraka Bhasma. Chemical composition: It contains Magnesium, Iron, Potassium, Calcium and Aluminium. Makardhwaj rasa: Purified Swarn Gold pieces 11.6638038 grams are blended with Purified Mercury and Purified Sulphur in the ratio of 1:2:4 and thoroughly blended for 6-7 hours every day over a period of 7 days to form Black Sulphide of Mercury (The
  4. 4. greater period the mixture is blended the better quality is obtained). Black Sulphide of Mercury is then treated with the red flowers of Bombax ceiba (Cotton Tree) juice and Aloe Vera juice 3 times each. The mixture is dried and transferred to a glass flask. The flask is layered 7 times with cloth plastered with wet-mud/clay is cooked in a sand and gadget apparatus (see below) for 24hours. On cooling red-coloured Makardhwaj is collected. In classical Ayurveda formulations, makardhwaj is used as a sexual stimulant and vitalizer (Sinyorita et al., 2011) and is never used by itself but always used in combination with medicinal plants. Rasa sindura or Mercuric Sulphide: Take of mercury and sulphur equal parts, and prepare Rasa sindura as already described by sublimation in a glass bottle. Ashtavarga (group of eight medicinal plants): 1. Malaxis muscifera, The Fly Bearing Makaxis (Medicinal Orchid) - Increases seminal fluid. 2. Malaxis acuminate, The Gradually Tapering Malaxis (Medicinal Orchid) - Aphrodisiac 3. Polygonum verticilliatum, Polygonaceae Rhizome - Increases seminal fluid. 4. Polygonum cirrifolium, Polygonaceae Rhizome - Increases seminal fluid. 5. Roscoea procera, Ginger Root - Aphrodisiac 6. Fritillaria royeli, Liliaceae Root - Tonic 7. Habenaria intermedia, Wild Orchid (Medicinal Orchid) - Tonic and increases seminal fluid 8. Habenaria edgeworthii, (Medicinal Orchid) - Tonic and increases seminal fluid Additional ingredients: Sodium Methyl Paraben, Sodium Propyl Paraben b) Dose, Dose Schedule, Route of administration:
  5. 5. Dosage: Tablet Adult: Sperm count 5 millions/ml to 10 millions/ml : 2 capsules twice a day for 90 days. Sperm count > 10 millions/ml : 1 Capsule twice a day for 90 days. It is recommended to go for a repeat sperm count at least 6 wks after start of treatment; as that is the time spermatozoa takes to become a mature sperm. Dosage of addyzoa is 2 capsules thrice a day for 90 days; but it takes at least 6 weeks for the results to show. Studies have proven that regular sex is better for pregnancy than timed intercourse. You can have sex while on Addyzoa therapy. Oral c) Therapeutic/diagnostic claims: Male Functional Infertility-Oligo, Asthno and Teratospermia Benefits 1) Increases Sperm Count 2) Enhances Sperm motility 3) Improves Sperm Morphology (prevents DNA damage to sperms) 4) Enhances the chances of pregnancy 5) Increases sexual desire. d) Description of dosage form being registered: 100 CAPSULES (05 STRIPS OF 20 CAPSULES) Approved colours used in empty gelatin capsules. e) Pharmacological properties. Pharmacodynamics. THERAPEUTIC RATIONALE ADDYZOA is a herbomineral spermatogenic antioxidant. ADDYZOA has multifaceted free radical scavenging action and therefore, ADDYZOA minimizes
  6. 6. effectively the damage to the sperm cells due to reactive oxygen species (ROS). ROS (reactive oxygen species) are molecules that play a role in male factor infertility. Addyzoa effectively minimises this damage to the sperm cells due to ROS. Withania somnifera, Tinospora cordifolia and Emblica officinalis are potent antioxidants in ADDYZOA, which act by reducing the excessive oxidative stress, which is responsible for sperm damage. Shilajit shuddha, Mucuna pruriens shuddha and Withania somnifera improve sperm count. Asparagus racemosus increases spermatogenesis by regeneration of seminiferous tubules. Thus, ADDYZOA improves sperm count, motility and morphology and also increases semen density. ADDYZOA has been widely used for the empirical treatment of male infertility for more than 3 decades, has only been sporadically evaluated in this condition. According to Thakre and Thakre, this herbo-mineral preparation improved the quality and quantity of semen by increasing sperm count and motility. Treatment with Cow-Itch significantly improved testosterone (T), LH, dopamine,adrenaline, and noradrenaline levels in infertile men and reduced levels of FSH and PRL. Sperm count and motility were significantly recovered in infertile men after treatment. Treatment with M. pruriens regulates steroidogenesis (production of steroids by the adrenal glands) and improves semen quality in infertile men. Antioxidants present in Addyzoa such as Vitamin-C from Amla (Indian Gooseberry) and Ashwagandha( Winter Cherry), help to restore the properper oxidant; antioxidant balance, thus maintaining the genetic integrity of sperm cells by preventing oxidative damage to sperm DNA. Asparagus recemosus, present in the dose of 25 mg may help in regeneration of seminiferous tubules and thus cause an increase in spermatogenesis. Action Clinical Pharmacology Spermatogenesis: Purnachandrodaya rasa, Makardhwaj rasa, Eulophia campestris, Mercuric Sulphide, Suvarnamakshik bhasma, China Root, Sweet Potato, Indian Gooseberry, India Spider Plant, Cow-Itch, Winter Cherry, Puncture Vine, Country Mallow Nervine Tonic & Tranquilizer: Asparagus, Winter Cherry, Abhraka Bhasma, Suvarnamakshik, Muktashukti bhasma Nutritive: Tacca aspera, Hawaiian Baby Woodrose, Sweet Potato, Country Mallow, Winter Cherry
  7. 7. Rejuvenator: Indian Gooseberry, Heart-Leaved Moonseed, Asparagus, Winter Cherry Premature ejaculation & oligospermia: Indian Spider Plant Improves sperm count: Asphaltum, Cow-Itch Antioxidant &protects sperm from ROS: Heart-Leaved Moonseed, Indian Gooseberry Antioxidant, sperm count, sperm motility: Winter Cherry, f) Pharmacokinetics. Whereas Addyzoa® is a multicomponent preparation, its kinetics caused by an additive effect of its components and conducting trials is impossible. Actions: Addyzoa® Increases Sperm Count, enhances sperm motility, improves sperm morphology (prevents DNA damage to sperms), prevents premature ejaculation, enhances the chances of pregnancy and acts as an aphrodisiac. g) Contraindication/precautions: Use only under medical supervision. Drugs interactions: It is generally recommended to take Addyzoa alone. However, in practice for cases of severe oligoasthenospermia, Addyzoa can safely be administered with the Drug Clomid. h) Adverse effects: The drug was well-tolerated and there were no adverse effects in either group. No adverse effects were reported during the treatment. i) Symptoms of Overdose: Nausea and vomiting j) Treatment of Overdosage: Stomach wash and symptomatic treatment
  8. 8. k) Toxic effects, and protocol for treating toxicity or where applicable, antidote. The drug was well-tolerated and there were no adverse effects in either group. No adverse effects were reported during the treatment. The result of acute toxicity studies conducted by K.M. Kundanani College of Pharmacy clearly indicates that there were no toxic effects or deleterious reactions of any clinical significance induced by Addyzoa Capsules in mice by oral route. Refer to Toxicity Studies Dossier for details. l) A. Shelf life: Shelf life of Addyzoa is 36 months from the date of manufacturing. B. Storage conditions: Keep it out of reach of children. Store in a dry place; away from direct sunlight at the temperature not more than 25º С. m) Presentation and pack size: Blister Packs conveniently presented for patient use. ___________________________________________________? n) Manufacturer: CHARAK PHARMA PVT. LTD. o)