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ALTRAM (tramadol hydrochloride tablets) is a centrally acting analgesic. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanolInactive ingredients in the tablet are corn starch, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and wax.

INDICATIONS
ALTRAM is indicated for the management of moderate to moderately severe pain in adults.

DOSAGE AND ADMINISTRATION
Adults (17 years of age and over)
For patients with moderate to moderately severe chronic pain not requiring rapid onset of analgesic effect, the tolerability of ALTRAM can be improved by initiating therapy with the following titration regimen: ALTRAM should be started at 25 mg/day qAM and titrated in 25 mg increments as separate doses every 3 days to reach 100 mg/day (25 mg q.i.d.). Thereafter the total daily dose may be increased by 50 mg as tolerated every3days to reach 200 mg/day (50 mg q.i.d.). After titration, ALTRAM 50 to 100 mg can be administered as needed for pain relief every 4 to 6 hours not to exceed 400 mg/day.

For the subset of patients for whom rapid onset of analgesic effect is required and for whom the benefits outweigh the risk of discontinuation due to adverse events associated with higher initial doses, ALTRAM 50 mg to 100 mg can be administered as needed for pain relief every four to six hours, not to exceed 400 mg per day.

USES
This medication is used to relieve moderate pain. It is similar to narcotic pain medications. It works on certain nerves in the brain that control how you experience pain.

CONTRAINDICATIONS
ALTRAM should not be administered to patients who have previously demonstrated hypersensitivity to tramadol, any other component of this product or opioids.ALTRAM is contraindicated in any situation where opioids are contraindicated, including acute intoxication with any of the following: alcohol, hypnotics, narcotics, centrally acting analgesics, opioids or psychotropic drugs. ALTRAM may worsen central nervous system and respiratory depression in these patients.



SIDE EFFECTS
Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, headache, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, maintain a diet adequate in fiber, drink plenty of water, and exercise. If you are taking tramadol regularly, it may be useful to start using a laxative right away instead of waiting until you become constipated. Consult your pharmacist for details regarding the correct use of laxatives (e.g., stimulant-type with stool softener).

This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs (see Drug Interactions section). Seek immediate medical attention if you develop some of the following symptoms: mental/mood changes (such as agitation, hallucinations), unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles.

PRECAUTIONS
Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain bowel diseases (paralytic ileus), brain disorders (e.g., seizures, increased intracranial pressure), conditions that increase the risk of seizures (e.g., head injury, brain tumors, meningitis, metabolic disorders, alcohol/drug withdrawal), adrenal gland problem (e.g., Addison's disease), difficulty urinating (e.g., enlarged prostate, urethral narrowing), heart problems (e.g., irregular heartbeat), personal or family history of regular use/abuse of drugs/alcohol, kidney disease, liver disease, lung diseases (e.g., chronic obstructive pulmonary disease-COPD, hypoxia), disease of the pancreas (e.g., pancreatitis), mental/mood conditions (e.g., major depression, toxic psychosis), a certain spinal problem (kyphoscoliosis), stomach/intestinal problems (e.g., gallbladder disease), underactive thyroid (hypothyroidism).

This drug may make you dizzy or drowsy. Use caution while driving, using machinery, or doing any activity that requires alertness. Avoid alcoholic beverages because they may increase the risk of this drug's side effects.

To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Caution is advised when using this drug in the elderly because they may be more sensitive to its effects, especially slow/shallow breathing and drowsiness.

STORAGE
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom.

Tramadol (INN) (pronounced /ˈtræmədɒl/) (Tramal, Ultram, Mabron, Ralivia, Ryzolt, Tradonal, Tramacet, Tridural, Ultracet, Zamadol, Zydol, Zytram) is a centrally acting analgesic, used for treating moderate to severe pain.

Tramadol was developed by the German pharmaceutical company Grünenthal GmbH in the late 1970s.

Tramadol possesses agonist actions at the μ-opioid receptor and affects reuptake at the noradrenergic and serotonergic systems. Tramadol is a compound with mild and delayed μ-agonist activity.

Tramadol is a synthetic stripped-down piperidine analog of Codeine and, as such, is an opioid. Opioids are chemical compounds which agonise one or more of the human opiate receptors, regardless of the receptor class or sub-type. The opioid agonistic effect of tramadol and its major metabolite(s) is almost complete exclusively effects the μ-opioid receptor. This characteristic is notable, because even morphine is not exclusive to the μ-receptor, although it manifests the preponderance of its opioid agonistic effects here.

Tramadol is used to treat moderate to moderately severe pain and most types of neuralgia, including trigeminal neuralgia. Tramadol is like levorphanol (albeit with much lower mu-agonism), somewhat, pharmacologically, as both opioids are also NMDA-antagonists which also have SNRI activity. It has been suggested(and proven in many people) that tramadol could be effective for alleviating symptoms of depression, anxiety, and phobias because of its action on the noradrenergic and serotonergic systems. However, health professionals have not endorsed its use for these disorders..

Tramadol is usually marketed as the hydrochloride salt (tramadol hydrochloride); the tartrate is seen on rare occasions, and rarely(in the US at least) Tramadol is available in both injectable (intravenous and/or intramuscular). It is also available in conjunction with acetaminophen(APAP) as Ultracet, an overly expensive non-generic form of a smaller dose of 37.5MG Tramadol and 325MG of APAP. Many patients and recreational users have firmly stated preference of the cheap 50MG generic Tramadol as well as the higher-MG extended-release versions). The solutions suitable for injection are used in Patient-Controlled Analgesia pumps under some circumstances, either as the sole agent or along with another agent such as morphine.

Tramadol comes in many forms, including:

* capsules

* tablets

* extended-release tablets

* extended-release capsules

* chewable tablets

* low-residue and/or uncoated tablets that can be taken by the sublingual and buccal routes

* suppositories

* effervescent tablets and powders

* ampoules of sterile solution for SC, IM, and IV injection

* preservative-free solutions for injection by the various spinal routes (epidural, intrathecal, caudal, and others)

* powders for compounding

* liquids both with and without alcohol for oral and sublingual administration, available in regular phials and bottles, dropper bottles, bottles with a pump similar to those used with liquid soap and phials with droppers built into the cap

* tablets and capsules containing (acetaminophen/APAP), aspirin and other agents.

Tramadol has been experimentally used in the form of an ingredient in multi-agent topical gels, creams, and solutions for nerve pain, rectal foam, concentrated retention enema, and a skin plaster (transdermal patch) quite similar to those used with lidocaine.

Tramadol has a characteristic taste which is mildly bitter but much less so than morphine and codeine. Oral and sublingual drops and liquid preparations come with and without added flavoring. Its relative effectiveness via transmucousal routes (sublingual, buccal, rectal) is around that of codeine, and, like codeine, it is also metabolized in the liver to stronger metabolites (see below).

The maximum dosage for tramadol in any form is 400 mg/day. Certain manufacturers or formulations have lower maximum doses. For example, Ultracet (37.5 mg/325 mg tramadol/APAP tablets) is capped at 8 per day (300 mg/day). Other popular formulations such as Ultram ER are available in 100, 200, and 300 mg/day doses. Patients with impaired liver function or using SSRIs should consult with their doctor regarding adjusted dosing.

The molecular weight of tramadol hydrochloride is 299.8. Tramadol hydrochloride is a white, bitter, crystalline and odorless powder. It is readily soluble in water and ethanol and has a pKa of 9.41. The n-octanol/water log partition coefficient (logP) is 1.35 at pH 7. ULTRAM® tablets contain 50 mg of tramadol hydrochloride and are white in color. Inactive ingredients in the tablet are pregelatinized corn starch, modified starch (corn), hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate, titanium dioxide and carnauba wax.

Tramal

Generic Name: Tramadol hydrochloride

Product Name: Tramal

* Indication of Tramal

* Action of Tramal

* Dose Advice of Tramal

* Schedule of Tramal

* Common side effects of Tramal

* Uncommon side effects of Tramal

Indication of Tramal:

Tramal is a strong painkiller used in the treatment and prevention of moderate to severe pain.

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Action of Tramal:

This medicine contains the active ingredient tramadol hydrochloride, which is a type of medicine called an opioid analgesic or painkiller. Opioid painkillers work by mimicking the action of naturally occurring pain-reducing chemicals called endorphins. Endorphins are found in the brain and spinal cord and reduce pain by combining with opioid receptors. Tramadol mimics the action of our natural endorphins by combining with the opioid receptors in the brain and spinal cord. This blocks the transmission of pain signals sent by the nerves to the brain. Therefore, even though the cause of the pain may remain, less pain is actually felt. Tramadol also works by enhancing the activity of neurotransmitters in the brain and spinal cord. Neurotransmitters are chemical compounds that act as chemical messengers between the nerve cells. Tramadol enhances the effect of the neurotransmitters serotonin and noradrenaline, and this action also helps relieve pain.

Table of Contents

* 1. NAME OF THE MEDICINAL PRODUCT

* 2. QUALITATIVE AND QUANTITATIVE COMPOSITION

* 3. PHARMACEUTICAL FORM

* 4. CLINICAL PARTICULARS

* 4.1 Therapeutic indications

* 4.2 Posology and method of administration

* 4.3 Contraindications

* 4.4 Special warnings and precautions for use

* 4.5 Interaction with other medicinal products and other forms of interaction

* 4.6 Pregnancy and lactation

* 4.7 Effects on ability to drive and use machines

* 4.8 Undesirable effects

* 4.9 Overdose

* 5. PHARMACOLOGICAL PROPERTIES

* 5.1 Pharmacodynamic properties

* 5.2 Pharmacokinetic properties

* 5.3 Preclinical safety data

* 6. PHARMACEUTICAL PARTICULARS

* 6.1 List of excipients

* 6.2 Incompatibilities

* 6.3 Shelf life

* 6.4 Special precautions for storage

* 6.5 Nature and contents of container

* 6.6 Special precautions for disposal and other handling

* Administrative Data

* 7. MARKETING AUTHORISATION HOLDER

* 8. MARKETING AUTHORISATION NUMBER(S)

* 9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

* 10. DATE OF REVISION OF THE TEXT

When you must not use it

Do not take TRAMADOL if you:

* are allergic to tramadol or to any of the other ingredients;

* have been drinking alcohol or taking other medicines that affect the nervous system such as hypnotics (used to relieve sleeplessness; e.g., nitrazepam), opioids (used to relieve moderate to severe pain; e.g., morphine and codeine) or psychotropic drugs (e.g., chlorpromazine; used to treat schizophrenia and severe anxiety);

* have had a head injury or feel faint from shock;

* are also taking drugs known as monoamine oxidase inhibitors (e.g., phenelzine and isocarboxazid), which are used to treat depression, or have been taking them within the past two weeks.

Tramadol may make you sleepy so be careful about driving or operating machinery.

Before you have a general anaesthetic, tell your doctor if you are taking Tramadol.

Before you start to use it,

Tell your doctor if you:

* suffer from kidney or liver disease

* suffer from epilepsy or convulsions or have had them in the past

* suffer from asthma or have trouble breathing

* are taking antidepressant drugs known as selective serotonin re-uptake inhibitors (e.g., fluoxetine and paroxetine) and tricyclic antidepressants (e.g., amitriptyline and desipramine) or carbamazepine (used to treat epilepsy and manic-depressive illness) or lithium (used to treat mania and depression)

* are pregnant or breast-feeding

How to take TRAMADOL capsules

How much to take

The directions given may differ from information contained in this leaflet.

Always take Tramadol exactly as your doctor tells you to.

Your pharmacist will help if you are not sure.

For moderate pain, one Tramadol capsule may be sufficient for the first dose, followed by one or two capsules two to three times a day as required.

For moderate to severe pain, two Tramadol capsules are usually required for the first dose, followed by one or two capsules every four to six hours as required.

Do not take more than eight Tramadol capsules (400mg) in 24 hours.

Tramadol capsules are not recommended for use in children under 12 years of age.

Elderly people over 75 years of age may require a lower daily dose.

How to take it

Tramadol capsules should be swallowed whole with a glass of water.

If you forget to take it

Take your dose as soon as you remember and then go on as before. Do not take a double dose to make up the forgotten dose.

μ-opioid binding. Tramadol-induced analgesia is only partially antagonized by the opiate antagonist naloxone in several animal tests. The relative contribution of both tramadol and M1 to human analgesia is dependent upon the plasma concentrations of each compound (see CLlNlCAL PHARMACOLOGY, Pharmacokinetics).

Tramadol has been shown to inhibit reuptake of norepinephrine and serotonin in vitro, as have some other opioid analgesics. These mechanisms may contribute independently to the overall analgesic profile of tramadol hydrochloride. Analgesia in humans begins approximately within one hour after administration and reaches a peak in approximately two to three hours.

Apart from analgesia, tramadol hydrochloride administration may produce a constellation of symptoms (including dizziness, somnolence, nausea, constipation, sweating and pruritus) similar to that of other opioids. In contrast to morphine, tramadol has not been shown to cause histamine release. At therapeutic doses, tramadol hydrochloride has no effect on heart rate, left-ventricular function or cardiac index. Orthostatic hypotension has been observed.

Pharmacokinetics:The analgesic activity of tramadol hydrochloride is due to both parent drug and the M1 metabolite (see CLINICAL PHARMACOLOGY, Pharmacodynamics). Tramadol is administered as a racemate and both the [-] and [+] forms of both tramadol and M1 are detected in the circulation. Tramadol is well absorbed orally with an absolute bioavailability of 75%. Tramadol has a volume of distribution of approximately 2.7L/kg and is only 20% bound to plasma proteins. Tramadol is extensively metabolized by a number of pathways, including CYP2D6 and CYP3A4, as well as by conjugation of parent and metabolites. One metabolite, M1, is pharmacologically active in animal models. The formation of M1 is dependent upon CYP2D6 and as such is subject to inhibition, which may affect the therapeutic response (see PRECAUTIONS - Drug Interactions). Tramadol and its metabolites are excreted primarily in the urine with observed plasma half-lives of 6.3 and 7.4 hours for tramadol and M1, respectively. Linear pharmacokinetics have been observed following multiple doses of 50 and 100 mg to steady-state.

Absorption: Racemic tramadol is rapidly and almost completely absorbed after oral administration. The mean absolute bioavailability of a 100 mg oral dose is approximately 75%. The mean peak plasma concentration of racemic tramadol and M1 occurs at two and three hours, respectively, after administration in healthy adults. In general, both enantiomers of tramadol and M1 follow a parallel time course in the body following single and multiple doses although small differences (~10%) exist in the absolute amount of each enantiomer present.

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