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By: B. Farmon, M.B.A., M.B.B.S., M.H.S.

Clinical Director, Oregon Health & Science University School of Medicine

Procedures to be adapted by the zonal officers to discharge the following functions that has been delegated recently by the Drugs Controller General of India under Rule 22 of the Drugs & Cosmetic Rules 1 hiv infection rate san diego buy prograf discount. Objection certificate for the grant of licence to manufacture drugs for the purpose of examination hiv infection rates us map prograf 1 mg free shipping, test or analysis and provided under Rule 89 of the Drugs & Cosmetic Rules anti viral remedies cheap prograf line. Objection certificate for the grant of permission for manufacture for export only of unapproved/ approved new drugs and drugs banned under section 26-A of the Drugs & Cosmetic Act. Issue of Permit for import of small quantities of drugs for personal use under Form-12B of the Drugs & Cosmetic Rules. Objection certificate for the grant of permission for import of dual use items, not for medicinal use. Other activities (workshop, seminar, meetings, trainings organized / attended) 20 350 300 250 200 150 100 50 0 Other Activities No. Compliance verification inspection to authenticate the results of corrective actions. A review should be made relating to the firm to be visited from the documents available in the office file. Communication with the Local Authority for access to the site of inspection and regarding the Schedule of inspection. Inspector shall act according to the procedures for handling of confidential information. All information observed or passed to the inspector is confidential and shall not be disclosed to anybody other than his controlling authority. Inspector shall neither carry with him any written or printed materials relating to other units nor disclose any information relating to another company. The inspector’s task is not only to point out deficiencies but also to provide guidance based on scientific evidence. At the opening session:- The inspection usually begins with a meeting between the inspector(s), representatives of the firm or plant management and those responsible for the product or areas to be inspected. The inspection team shall give a written day wise plan for the inspection schedule as per Annexure- A 5. The inspector(s) shall inform to the firm management to ensure presence of concerned in-charge of the respective areas as per inspection plan. The inspectors shall state which documents they need to examine once they have completed their preliminary tour of the site. There will be a preliminary tour of the site to allow the inspectors to get a general orientation of the site. It is recommended that the inspecting team start the plant tour as soon as possible after arrival. Over the course of the inspection the inspectors shall review all procedures, production and laboratory records, validations and any other record or documentation relating to production and control of the production process. The inspection shall also include detailed tours of all production facilities, laboratories, stores, utilities, the plant’s record and documentation centre. The documents such as master formulae, test specifications, Standard Operating Procedures, batch records (including protocols of analysis and documents relating to the control of printed material and labelling operations) requires close verification. The inspection team may adopt the additional and other plan for areas of inspection based on the need of particular inspection for the required purpose. A detailed listing of the findings and deficiencies found by the inspectors during the course of their inspection; 5. Issues of non-compliance observed during inspections shall be noted, discussed with firm representatives and handed over a copy of the same. The checklist for inspection of manufacturing units is a general example and need to be adopted as per specific need of the inspection and the products, e. The report of Inspection shall be completed in all respects as per the checklist and submitted to the Controlling Authority for review, comments and for further necessary action as early as possible. For review, correction & approval of checklist and draft - Should be done by Technical Head of the Department.

Pharmacodynamics In the kidneys antiviral nclex questions buy discount prograf online, carbonic anhydrase inhibitors decrease the availability of hydrogen ions hiv infection swollen lymph nodes generic prograf 5 mg without prescription, which blocks the sodium- hydrogen exchange mechanisms antiviral drip purchase discount prograf line. As a result, urinary excre- tion of sodium, potassium, bicarbonate, and water increases. Don’t lose your sense of humor In the eyes, carbonic anhydrase inhibition reduces aqueous humor production, which reduces intraocular pressure. Pharmacotherapeutics Carbonic anhydrase inhibitors are used for diuresis and to treat glaucoma. Drug interactions Adverse Carbonic anhydrase inhibitors produce a variety of drug interac- reactions to tions: carbonic • Salicylates may cause carbonic anhydrase inhibitor toxicity, in- anhydrase cluding central nervous system depression and metabolic acido- sis. They include darifenacin, flavoxate, oxybutynin, solife- How oxybutynin nacin, tolterodine, and trospium. These drugs are all widely dis- bladder, stimulating tributed, metabolized in the liver, and excreted in urine. Urinary tract antispasmodics relieve smooth muscle spasms by in- This anticholinergic ef- hibiting parasympathetic activity, which causes the detrusor and fect is what makes oxy- urinary muscles to relax. Flavoxate and oxybutynin also exhibit butynin useful in the many anticholinergic effects. Pharmacotherapeutics Urinary tract antispasmodics are used for patients with overactive bladders who have symptoms of urinary frequency, urgency, or in- continence. Urgent symptoms Trospium is also indicated for patients with overactive bladders who have symptoms of urge urinary incontinence, and oxybutynin acts as an antispasmodic for uninhibited or reflex neurogenic bladder. Adverse reactions to urinary tract antispasmodics Possible adverse reactions to urinary tract • constipation antispasmodics include: • nausea • blurred vision • vomiting • headache • weight gain • somnolence • pain • urinary retention • acute and secondary angle-closure • dry mouth glaucoma. This type of erectile dysfunction usually stems from vascular and neurologic conditions. Drugs used for erectile dys- function include alprostadil, sildenafil, tadalafil, and vardenafil. The majority of these drugs—including sildenafil, tadalafil, and vardenafil—are given orally, metabolized in the liver, and excreted in feces. An exceptional drug Alprostadil is the exception: it’s administered directly into the cor- pus cavernosum, metabolized in the lungs, and excreted in urine. Pharmacodynamics Sildenafil, tadalafil, and vardenafil selectively inhibit the phospho- diesterase type 5 receptors, which causes an increase in blood lev- els of nitric oxide. Alprostadil acts locally, promoting smooth muscle relaxation, which causes an increase in blood flow to the corpus cavernosum and produces an erection. Adverse reactions to erectile dysfunction drugs Adverse reactions to erectile dysfunction • headache drugs include: • dizziness • decreased supine blood pressure and car- • flushing diac output • dyspepsia • increased risk of cardiovascular events, in- • vision changes cluding myocardial infarction, sudden cardiac • prolonged erections (more than 4 hours), death, ventricular arrhythmias, cerebrovascu- which can result in irreversible damage to lar hemorrhage, transient ischemic attack, and erectile tissue Sometimes we just hypertension • penile pain (with alprostadil). Sildenafil is also indicated for potentially serious the treatment of pulmonary arterial hypertension. Drug interactions Erectile dysfunction drugs may interact with other drugs in the following ways: • Nitrates and alpha-adrenergic blockers used in combi- nation with erectile dysfunction drugs may cause severe hypotension and potentially serious cardiac events. For example, ethinyl estradiol may be combined with desogestrel, drospirenone, lev- onorgestrel, norethindrone, norgestimate, or norgestrel. Ethinyl estradiol or ethynodiol diacetate may also be used alone as a contraceptive. Patch power Some forms of hormonal contraceptives are available in a trans- dermal patch form. These contraceptives are absorbed through the skin but have the same distribution, metabolism, and excre- tion as orally administered contraceptives. The primary mechanism of action of combination hormonal con- traceptives (estrogen and progestin) is the suppression of go- nadotropins, which inhibits ovulation. Estrogen suppress- es secretion of follicle-stimulating hormone, which blocks follicular development and ovulation. Progestin suppress- es the secretion of luteinizing hormone, which prevents ovulation, even if the follicle develops.

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Inhaled forms are preferred because they act locally in adrenergic the lungs hiv infection diagram order prograf 1 mg free shipping, resulting in fewer adverse reactions than systemically agonists provide relief that’s fast! Pharmacotherapeutics (how drugs are used) Short-acting inhaled beta2-adrenergic agonists are the drugs of choice for fast relief of symptoms in the patient with asthma hiv infection rate swaziland 5 mg prograf visa. Safe and sound Problems with long-acting beta2-adrenergic agonists Adverse reactions If a patient is taking a long-acting beta2-adrenergic agonist hiv infection rate japan discount prograf online master card, make sure that he’s using it only as part of a combination therapy with other medications such as inhaled corticosteroids. Patients to beta2- who use long-acting beta2-adrenergic agonists as their only means of asthma control are at seri- adrenergic ous risk for adverse effects, including death. They aren’t used to relieve acute symptoms because Adverse reactions their onset of action isn’t fast enough. They also don’t affect the to long-acting beta2- chronic inflammation associated with asthma. Ipratropium Ipratropium is the most common anticholinergic used for respira- tory disorders. Adverse Pharmacodynamics reactions to Ipratropium inhibits muscarinic receptors, which results in bron- chodilation. This drug works by blocking the parasympathetic ner- anticholinergics vous system, rather than stimulating the sympathetic nervous sys- The most common ad- tem. They’re less effective in long-term management of the pa- • nausea and vomiting tient with asthma; however, they may be used as adjunctive thera- • paradoxical bron- py (usually in combination with a short-acting beta2-adrenergic ag- chospasm (with exces- onist on a scheduled basis). Iprat- ropium should be used cautiously with antimuscarinic drugs and other anticholinergics. Inhaled corticosteroids include: • beclomethasone dipropionate • budesonide • flunisolide • fluticasone • triamcinolone acetonide. The amount found in breast milk can be minimized • Elderly patients: May benefit from receiving drugs that pre- if the woman waits at least 4 hours after taking prednisone to vent osteoporosis, such as alendronate during therapy with breast-feed her infant. Pharmacokinetics Oral prednisone is readily absorbed and extensively metabolized in the liver to the active metabolite prednisolone. Inhaled drugs are minimally absorbed, although absorption increases as the dosage is increased. Pharmacodynamics Corticosteroids are the most Corticosteroids work by inhibiting the production of cytokines, effective drugs for leukotrienes, and prostaglandins; the recruitment of eosinophils; the long-term and the release of other inflammatory mediators. They also affect treatment and other areas in the body, which can cause long-term adverse reac- prevention of acute asthma tions. Pharmacotherapeutics Corticosteroids are the most effective drugs available for the long- term treatment and prevention of acute asthma attacks. Inhalation for prevention Inhaled corticosteroids are the preferred drugs for preventing fu- ture attacks in the patient with mild to severe asthma. Use of in- haled corticosteroids reduces the need for systemic steroids in many cases, thus reducing the patient’s risk of developing serious long-term adverse reactions. Systemic corticosteroids should be used at the lowest effective dosage and for the shortest Warning! To reduce the risk of Leukotriene modifiers are used for the prevention and long-term adverse reactions from control of mild asthma. Zafirlukast’s absorption is de- creased by food, so it should be given 1 hour before or 2 hours af- ter meals. In general, this class of drugs is metabolized, induced, or inhibited by the cytochrome P450 en- zyme system, which is important for establishing drug interac- tions. Caution required Zileuton is contraindicated in the patient with active liver disease. Closely monitor the patient with liver impairment who’s taking zafirlukast for adverse reactions; he may require a dosage adjust- ment. Leukotrienes can The leukotriene receptor antagonists zafirlukast and montelukast be very trying for prevent the D4 and E4 leukotrienes from interacting with their re- asthma sufferers. The leukotriene formation Montelukast, inhibitor zileuton inhibits the production of 5-lipoxygenase, there- zafirlukast, and zileuton help to inhibit by preventing the formation of leukotrienes. Pharmacotherapeutics Leukotriene modifiers are primarily used to prevent and control asthma attacks in the patient with mild to moderate disease.

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